FDA Product Classification Codes Begining with "M"


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FDA Device Classification Medical Specialty FDA Product Code FDA Regulation Number Device Class 510k Exempt?
M. LYSODEIKTICUS CELLS (SPECTROPHOTOMETRIC), LYSOZYME (MURAMIDASE) Clinical Chemistry JMQ 862.1490 1 Y
MAGNET, AC-POWERED Opthalmic HPO 886.4440 2 N
MAGNET, CONTINENT COLOSTOMY Gastroenterology/Urology KPG N
MAGNET, PERMANENT Opthalmic HPN 886.4445 1 Y
MAGNET, TEST, PACEMAKER Cardiovascular DTG 870.3690 1 Y
MAGNIFIER, HAND-HELD, LOW-VISION Opthalmic HJF 886.5540 1 Y
MAINTAINER, SPACE PREFORMED, ORTHODONTIC Dental DYT 872.5525 1 Y
MALACHITE GREEN Pathology KJY 864.1850 1 Y
MALLET General Plastic Surgery HXL 878.4800 1 Y
MALLET, SURGICAL, GENERAL & PLASTIC SURGERY General Plastic Surgery GFJ 878.4800 1 Y
MANIDBULAR CONDYLE PROSTHESIS Dental MPL 872.3960 3 N
MANIPULATOR, PLUNGER-LIKE JOINT Physical Medicine LXM N
MANOMETER, BLOOD-PRESSURE, VENOUS Cardiovascular KRK 870.1140 2 N
MANOMETER, SPINAL-FLUID General Hospital FMJ 880.2500 2 N
MANOMETER, WATER Gastroenterology/Urology FJA 876.5820 2 N
MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS Microbiology JWY 866.1640 2 N
MANUAL COLONY COUNTER Microbiology KZC 866.2180 1 Y
MARKER, CARDIOPULMONARY BYPASS (VEIN MARKER) Cardiovascular MAB N
MARKER, OCULAR Opthalmic HMR 886.4570 1 Y
MARKER, OSTIA, AORTO-SAPHENOUS VEIN General Plastic Surgery KPK 878.4650 2 N
MARKER, PERIODONTIC Dental EMP 872.4565 1 Y
MARKER, RADIOGRAPHIC, IMPLANTABLE General Plastic Surgery NEU 878.4300 2 N
MARKER, SCLERA Opthalmic HMQ 886.4570 1 Y
MARKER, SKIN General Plastic Surgery FZZ 878.4660 1 Y
MARKER, SUTURE IDENTIFICATION General Plastic Surgery MAW N
MARKER,COLON Gastroenterology/Urology NBG N
MARTIUS YELLOW Pathology KJZ 864.1850 1 Y
MASK, GAS, ANESTHETIC Anesthesiology BSJ 868.5550 1 Y
MASK, OXYGEN Anesthesiology BYG 868.5580 1 Y
MASK, OXYGEN, LOW CONCENTRATION, VENTURI Anesthesiology BYF 868.5600 1 Y
MASK, OXYGEN, NON-REBREATHING Anesthesiology KGB 868.5570 1 Y
MASK, SCAVENGING Anesthesiology KHA 868.5590 1 Y
MASK, SURGICAL General Plastic Surgery FXX 878.4040 2 N
MASK, VENTILATOR, NON-CONTINUOUS, REPROCESSED Anesthesiology NMC 868.5905 2 N
MASKER, TINNITUS Ear, Nose, Throat KLW 874.3400 2 N
MASS SPECTROMETER, CLINICAL USE Clinical Toxicology DOP 862.2860 1 Y
MASSAGER, POWERED INFLATABLE TUBE Physical Medicine IRP 890.5650 2 N
MASSAGER, THERAPEUTIC, ELECTRIC Physical Medicine ISA 890.5660 1 Y
MASSAGER, THERAPEUTIC, MANUAL Physical Medicine LYG 890.5660 1 Y
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID Dental LPG 3 N
MATERIAL, EXTERNAL AESTHETIC RESTORATION, NO ADHESIVE General Plastic Surgery NOK 878.3800 1 Y
MATERIAL, EXTERNAL AESTHETIC RESTORATION, USED WITH ADHESIVE General Plastic Surgery GBI 878.3800 1 Y
MATERIAL, IMPLANT, UTERINE, FOR ADHESIOGENIC EFFECT Obstetrics/Gynecology NHR N
MATERIAL, IMPRESSION Dental ELW 872.3660 2 N
MATERIAL, IMPRESSION TRAY, RESIN Dental EBH 872.3670 1 Y
MATERIAL, INVESTMENT Dental EGC N
MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTION General Plastic Surgery KKY 878.3500 2 N
MATERIAL, TOOTH SHADE, RESIN Dental EBF 872.3690 2 N
MATERIALS, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL ALVEOLAR RIDGE AUGMENTATION Dental NFE 872.3680 2 N
MATERIALS, REPAIR OR REPLACEMENT, PACEMAKER Cardiovascular KFJ 870.3710 3 N
MATRIX, DENTAL Dental DZN 872.4565 1 Y
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE General Hospital FNM 880.5550 2 Y
MATTRESS, FLOTATION THERAPY, NON-POWERED General Hospital IKY 880.5150 1 Y
MATTRESS, WATER, TEMPERATURE REGULATED General Hospital FOH 880.5560 1 Y
MAXWELL SPOT, AC-POWERED Opthalmic HIX 886.1435 1 Y
MEASURER, GINGIVAL FLUID Dental JEO 872.1500 1 Y
MEDIA AND COMPONENTS, MYCOPLASMA DETECTION Pathology KPB 864.2360 1 Y
MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE Pathology KIT 864.2220 1 Y
MEDIA, CORNEAL STORAGE Opthalmic LYX N
MEDIA, CULTURE, AMINO ACID ASSAY Microbiology JRZ 866.2350 1 Y
MEDIA, CULTURE, EX VIVO, TISSUE AND CELL Gastroenterology/Urology NDS 876.5885 2 N
MEDIA, ELECTROCONDUCTIVE Neurology GYB 882.1275 2 N
MEDIA, MOUNTING, OIL SOLUBLE Pathology KEP 864.4010 1 Y
MEDIA, MOUNTING, WATER SOLUBLE Pathology KEQ 864.4010 1 Y
MEDIA, MYCOPLASMA DETECTION Pathology KIX 864.2360 1 Y
MEDIA, POTENTIATING FOR IN VITRO DIAGNOSTIC USE Hematology KSG 864.9600 2 Y
MEDIA, REPRODUCTIVE Obstetrics/Gynecology MQL 884.6180 2 N
MEDIA, REUSABLE IMAGE Radiology LQA 892.1840 1 Y
MEDIA,COUPLING,ULTRASOUND Radiology MUI 892.1570 2 N
MEDIASTINOSCOPE, DIAGNOSTIC Gastroenterology/Urology GCH 876.1500 2 N
MEDIASTINOSCOPE, SURGICAL Ear, Nose, Throat EWY 874.4720 2 N
MEDICAL COMPUTERS AND SOFTWARE FOR OPHTHALMIC USE Opthalmic LQB 3 N
MEDIUM, CONTRAST, RADIOLOGIC Radiology KTA N
MELTING POT, PARAFFIN Pathology IDS 864.3010 1 Y
MEMBRANE OSMOMETRY, PLASMA ONCOMETRY Clinical Chemistry JNX 862.1530 1 Y
MEMBRANE, LUNG, (FOR LONG-TERM RESPIRATORY SUPPORT) Anesthesiology BYS 868.5610 3 N
MERCURIC NITRATE AND DIPHENYL CARBAZONE (TITRIMETRIC), CHLORIDE Clinical Chemistry CHK 862.1170 2 N
MERCURIC THIOCYANATE, COLORIMETRY, CHLORIDE Clinical Chemistry CHJ 862.1170 2 N
MERCURY Dental ELY 872.3700 1 N
MERCURY DITHIAZONE, COLORIMETRY, BARBITURATE Clinical Toxicology DJN 862.3150 2 N
MERCURY, ATOMIC ABSORPTION Clinical Toxicology DPH 862.3600 1 N
MESH, METAL General Plastic Surgery EZX 878.3300 2 N
MESH, SURGICAL General Plastic Surgery FTM 878.3300 2 N
MESH, SURGICAL, POLYMERIC General Plastic Surgery FTL 878.3300 2 N
METAL, BASE Dental EJH 872.3710 2 N
METANIL YELLOW Pathology HYY 864.1850 1 Y
METER, AIRWAY PRESSURE (INSPIRATORY FORCE) Anesthesiology BXR 868.1780 2 N
METER, CONDUCTIVITY, INDUCTION, REMOTE TYPE Gastroenterology/Urology FLB 876.5820 2 N
METER, CONDUCTIVITY, NON-REMOTE Gastroenterology/Urology FIZ 876.5820 2 N
METER, JAUNDICE General Hospital LMX 3 N
METER, PEAK FLOW, SPIROMETRY Anesthesiology BZH 868.1860 2 N
METHENAMINE SILVER Pathology HYZ 864.1850 1 Y
METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) Clinical Chemistry JIL 862.1340 2 N
METHOD, IMMUNODIFFUSION, IMMUNOGLOBULINS (G, A, M) Immunology CGM 866.5510 2 N
METHOD, ION-EXCHANGE, AMMONIA Clinical Chemistry JIE 862.1065 1 N
METHOD, METALLIC REDUCTION, GLUCOSE (URINARY, NON-QUANTITATIVE) Clinical Chemistry JIM 862.1340 2 N
METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) Immunology CFN 866.5510 2 N
METHOTREXATE CONTROL MATERIALS Clinical Toxicology LAY 862.3280 1 N
METHYL GREEN Pathology HZA 864.1850 1 Y
METHYL METACRYLATE FOR ANEURYSMORRHAPHY Neurology JXH 882.5030 2 N
METHYL METHACRYLATE FOR CRANIOPLASTY Neurology GXP 882.5300 2 N
METHYL ORANGE Pathology KKA 864.1850 1 Y
METHYL VIOLET 2B Pathology KKB 864.1850 1 Y
METHYLENE BLUE THIOCYANATE Pathology KKM 864.1850 1 Y
METHYLENE BLUE, TISSUE STAIN Pathology KFC 864.1850 1 Y
METHYLENE VIOLET Pathology KKC 864.1850 1 Y
METHYLTHYMOL BLUE, CALCIUM Clinical Chemistry CIA 862.1145 2 N
MICRO MIXER Clinical Chemistry JRB 862.2050 1 Y
MICRO PIPETTE Clinical Chemistry JRC 862.2050 1 Y
MICRO-CONDOM Obstetrics/Gynecology LZL 884.5320 3 N
MICROBIOLOGICAL, HISTIDINE Clinical Chemistry JMJ 862.1375 1 Y
MICRODEBRIDER, ENT, HIGH SPEED, SINGLE USE, REPROCESSED Ear, Nose, Throat NLY 874.4140 1 N
MICRODENSITOMETRY METHOD, LIPOPROTEINS Clinical Chemistry JHL 862.1475 1 Y
MICROFILTER, BLOOD TRANSFUSION General Hospital CAK 880.5440 2 N
MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION Obstetrics/Gynecology MQJ 884.6150 2 N
MICROMETERS, MICROSCOPE Pathology KEH 864.3600 1 Y
MICRORULE, ENT Ear, Nose, Throat KAH 874.4420 1 Y
MICROSCOPE AND MICROSCOPE ACCESSORIES,REPRODUCTION,ASSISTED Obstetrics/Gynecology MTX 884.6190 1 Y
MICROSCOPE, FLUORESCENCE/U.V. Pathology IBK 864.3600 1 Y
MICROSCOPE, INVERTED STAGE, TISSUE CULTURE Pathology IBL 864.3600 1 Y
MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC General Plastic Surgery HRM 878.4700 1 Y
MICROSCOPE, OPERATING, NON-ELECTRIC, OPHTHALMIC General Plastic Surgery HRB 878.4700 1 Y
MICROSCOPE, PHASE CONTRAST Pathology IBM 864.3600 1 Y
MICROSCOPE, SURGICAL General Plastic Surgery EPT 878.4700 1 Y
MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY General Plastic Surgery FSO 878.4700 1 Y
MICROSPHERE, TRACE Cardiovascular DQG 870.1360 3 N
MICROSPHERES,RADIONUCLIDE Radiology NAW N
MICROTITRATOR, FOR CLINICAL USE Clinical Chemistry JRA 862.2680 1 Y
MICROTOME, ACCESSORIES Pathology IDL 864.3010 1 Y
MICROTOME, CRYOSTAT Pathology IDP 864.3010 1 Y
MICROTOME, FREEZING ATTACHMENT Pathology IDN 864.3010 1 Y
MICROTOME, ROTARY Pathology IDO 864.3010 1 Y
MICROTOME, SLIDING Pathology KFL 864.3010 1 Y
MICROTOME, ULTRA Pathology IDM 864.3010 1 Y
MICROTOOL FABRICATION, ASSISTED REPRODUCTION Obstetrics/Gynecology MQI 884.6140 2 N
MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES) Obstetrics/Gynecology MQH 884.6130 2 N
MICROTRON, MEDICAL Radiology JAE 892.5050 2 N
MIRROR, ENT Ear, Nose, Throat KAI 874.4420 1 Y
MIRROR, GENERAL & PLASTIC SURGERY General Plastic Surgery FTX 878.4800 1 Y
MIRROR, MOUTH Dental EAX 872.4565 1 Y
MIXER, BLOOD TUBE Clinical Chemistry GLE 862.2050 1 Y
MIXER, BREATHING GASES, ANESTHESIA INHALATION Anesthesiology BZR 868.5330 2 N
MIXER, CEMENT, FOR CLINICAL USE Orthopedic JDZ 888.4210 1 Y
MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES Hematology GLQ 864.8625 2 N
MIXTURE, HEMATOLOGY QUALITY CONTROL Hematology JPK 864.8625 2 N
MOBILIZER, ENT Ear, Nose, Throat KAJ 874.4420 1 Y
MOLD, MIDDLE-EAR Ear, Nose, Throat ETC 874.3430 2 N
MOLD, VAGINAL Obstetrics/Gynecology HFK 884.3900 2 N
MOLYBDENUM BLUE METHOD, PHOSPHOLIPIDS Clinical Chemistry CEQ 862.1575 1 Y
MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS Cardiovascular DTW 870.4340 2 N
MONITOR, AIR EMBOLISM, ULTRASONIC Anesthesiology CBA 868.2025 2 N
MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) Anesthesiology CAP 868.2600 2 N
MONITOR, ALPHA Neurology GXS 882.1610 2 N
MONITOR, APNEA, FACILITY USE Anesthesiology FLS 868.2377 2 N
MONITOR, BED PATIENT General Hospital KMI 880.2400 1 Y
MONITOR, BLOOD-FLOW, CEREBRAL, THERMAL DIFFUSION Neurology LME 3 N
MONITOR, BLOOD-FLOW, ULTRASONIC Obstetrics/Gynecology HEP 884.2660 2 N
MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS Cardiovascular DRY 870.4330 2 N
MONITOR, CARBON-DIOXIDE, CUTANEOUS Anesthesiology LKD 868.2480 2 N
MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) Cardiovascular DRT 870.2300 2 N
MONITOR, CARDIAC, FETAL Obstetrics/Gynecology KXN 884.2600 2 N
MONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS General Hospital FLN 880.2420 2 N
MONITOR, ELECTROENCEPHALOGRAPHIC, FETAL (AND ACCESSORIES) Obstetrics/Gynecology HGO 884.2620 3 N
MONITOR, ESOPHAGEAL MOTILITY, AND TUBE Gastroenterology/Urology KLA 876.1725 2 N
MONITOR, EYE MOVEMENT Opthalmic HLL 886.1510 2 N
MONITOR, EYE MOVEMENT, DIAGNOSTIC Opthalmic HMC 886.1510 2 N
MONITOR, FETAL DOPPLER ULTRASOUND Radiology MAA 884.2660 2 N
MONITOR, HEART RATE, FETAL, NON-STRESS TEST (HOME USE) Obstetrics/Gynecology MOH 3 N
MONITOR, HEART RATE, FETAL, ULTRASONIC Obstetrics/Gynecology HEL 884.2660 2 N
MONITOR, HEART SOUND, FETAL, ULTRASONIC Obstetrics/Gynecology HEK 884.2660 2 N
MONITOR, HEART-VALVE MOVEMENT, FETAL, ULTRASONIC Obstetrics/Gynecology HEI 884.2660 2 N
MONITOR, HEMIC SOUND, ULTRASONIC Obstetrics/Gynecology HEJ 884.2660 2 N
MONITOR, INTRACRANIAL PRESSURE, IMPLANTED Neurology LII 3 N
MONITOR, LESION TEMPERATURE Neurology GXT 882.5500 2 N
MONITOR, LINE ISOLATION Cardiovascular DRI 870.2620 1 Y
MONITOR, LUNG WATER MEASUREMENT Anesthesiology JEZ 868.2450 3 N
MONITOR, MICROBIAL GROWTH Microbiology JTA 866.2560 1 Y
MONITOR, ORTHOTIC/PROSTHETIC Physical Medicine NHF 890.3025 1 Y
MONITOR, OXYGEN, CUTANEOUS, FOR INFANT NOT UNDER GAS ANESTHESIA Anesthesiology KLK 868.2500 2 N
MONITOR, OXYGEN, CUTANEOUS, FOR USES OTHER THAN FOR INFANT NOT UNDER GAS ANESTHESIA Anesthesiology LPP 868.2500 3 N
MONITOR, PATIENT POSITION, LIGHT-BEAM Radiology IWE 892.5780 1 Y
MONITOR, PENILE TUMESCENCE Gastroenterology/Urology LIL N
MONITOR, PHONOCARDIOGRAPHIC, FETAL Obstetrics/Gynecology HFP 884.2640 2 N
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) Cardiovascular MHX 870.1025 3 N
MONITOR, PRESSURE, ARTERIAL, FETAL, ULTRASONIC Obstetrics/Gynecology HEQ 884.2660 2 N
MONITOR, PRESSURE, INTRACOMPARTMENTAL Orthopedic LXC N
MONITOR, PRESSURE, INTRAUTERINE Obstetrics/Gynecology KXO 884.2700 2 N
MONITOR, SKIN RESISTANCE/SKIN TEMPERATURE, FOR INSULIN REACTIONS General Hospital LMY 3 N
MONITOR, SPINAL-FLUID PRESSURE, ELECTRICALLY POWERED General Hospital CAR 880.2460 2 N
MONITOR, SPINE CURVATURE Physical Medicine LZW N
MONITOR, ST SEGMENT Cardiovascular MLC 870.2340 2 N
MONITOR, ST SEGMENT WITH ALARM Cardiovascular MLD 870.1025 3 N
MONITOR, TEMPERATURE, DIALYSIS Gastroenterology/Urology FLA 876.5820 2 N
MONITOR, U.V., GLC Clinical Toxicology JXQ 862.2250 1 Y
MONITOR, ULTRASONIC, FETAL Obstetrics/Gynecology KNG 884.2660 2 N
MONITOR, ULTRASONIC, NONFETAL Radiology JAF 892.1540 2 N
MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) Obstetrics/Gynecology HFM 884.2720 2 N
MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) Cardiovascular MWI 870.2300 2 N
MONITOR,TEST,HIV-1 Hematology MTL 3 N
MONOCLONAL,HIV-1 Hematology MVY N
MOTOR, DRILL, ELECTRIC Neurology HBC 882.4360 2 N
MOTOR, DRILL, PNEUMATIC Neurology HBB 882.4370 2 N
MOTOR, SURGICAL INSTRUMENT, AC-POWERED General Plastic Surgery GEY 878.4820 1 Y
MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED General Plastic Surgery GET 878.4820 1 Y
MOUNTING MEDIA Pathology LEB 864.4010 1 Y
MOUTHGUARD Dental MQC N
MOUTHPIECE, BREATHING Anesthesiology BYP 868.5620 1 Y
MOUTHPIECE, SALIVA EJECTOR Dental DYN 872.6640 1 Y
MUCICARMINE Pathology HZC 864.1850 1 Y
MULLER'S COLLOIDAL IRON Pathology HZD 864.1850 1 Y
MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED AND UNASSAYED) Clinical Chemistry JJY 862.1660 1 N
MULTIPLE AUTOANTIBODIES, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL Immunology DBL 866.5660 2 N
MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL Immunology DDR 866.5680 2 N
MYOGLOBIN, FITC, ANTIGEN, ANTISERUM, CONTROL Immunology DEA 866.5680 2 N
MYOGLOBIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL Immunology DDO 866.5680 2 N


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