FDA Product Classification Codes Begining with "H"
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| FDA Device Classification |
Medical Specialty |
FDA Product Code |
FDA Regulation Number |
Device Class |
510k Exempt? |
| HALTER, HEAD, TRACTION |
Orthopedic |
HSS |
888.5890 |
1 |
Y |
| HAMMER, REFLEX, POWERED |
Physical Medicine |
IKO |
890.1450 |
2 |
N |
| HAMMER, SURGICAL |
General Plastic Surgery |
FZY |
878.4800 |
1 |
Y |
| HAND, EXTERNAL LIMB COMPONENT, MECHANICAL |
Physical Medicine |
IRA |
890.3420 |
1 |
Y |
| HAND, EXTERNAL LIMB COMPONENT, POWERED |
Physical Medicine |
IQZ |
890.3420 |
1 |
Y |
| HAND-TALLY, DIFFERENTIAL |
Hematology |
GKM |
864.6160 |
1 |
Y |
| HANDLE, INSTRUMENT, DENTAL |
Dental |
EJB |
872.4565 |
1 |
Y |
| HANDLE, SCALPEL |
General Plastic Surgery |
GDZ |
878.4800 |
1 |
Y |
| HANDPIECE (BRACE), DRILL |
Neurology |
HBD |
882.4325 |
1 |
Y |
| HANDPIECE, AIR-POWERED, DENTAL |
Dental |
EFB |
872.4200 |
1 |
N |
| HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL |
Dental |
EFA |
872.4200 |
1 |
N |
| HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL |
Dental |
EGS |
872.4200 |
1 |
N |
| HANDPIECE, DIRECT DRIVE, AC-POWERED |
Dental |
EKX |
872.4200 |
1 |
N |
| HANDPIECE, ROTARY BONE CUTTING |
Dental |
KMW |
872.4120 |
2 |
N |
| HANDPIECE, WATER-POWERED |
Dental |
EKY |
872.4200 |
1 |
N |
| HANDRIM, WHEELCHAIR |
Physical Medicine |
IMO |
890.3920 |
1 |
Y |
| HAPLOSCOPE |
Opthalmic |
HJT |
886.1340 |
1 |
Y |
| HAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DAD |
866.5460 |
2 |
Y |
| HAPTOGLOBIN, FITC, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DAB |
866.5460 |
2 |
Y |
| HAPTOGLOBIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
CZZ |
866.5460 |
2 |
Y |
| HEAD HALTER, TRACTION |
Physical Medicine |
IRS |
890.5925 |
1 |
Y |
| HEAD, SURGICAL, HAMMER |
General Plastic Surgery |
GFB |
878.4820 |
1 |
Y |
| HEADGEAR, EXTRAORAL, ORTHODONTIC |
Dental |
DZB |
872.5500 |
2 |
N |
| HEADLAMP, OPERATING, AC-POWERED |
Opthalmic |
HPQ |
886.4335 |
2 |
N |
| HEADLIGHT, FIBEROPTIC FOCUSING |
Opthalmic |
FCT |
886.4335 |
2 |
N |
| HEADREST, NEUROSURGICAL |
Neurology |
HBM |
882.4440 |
1 |
Y |
| HEARING AID, AIR CONDUCTION, TRANSCUTANEOUS SYSTEM |
Ear, Nose, Throat |
NIX |
874.3340 |
2 |
N |
| HEARING AID, BONE CONDUCTION, PERCUTANEOUS |
Ear, Nose, Throat |
MKE |
|
3 |
N |
| HEARING AID, DIRECT DRIVE, PARTIALLY IMPLANTED |
Ear, Nose, Throat |
MPV |
|
3 |
N |
| HEARING AID, SHAFER CORTICAL |
Ear, Nose, Throat |
MKP |
|
3 |
N |
| HEARING-AID, AIR-CONDUCTION |
Ear, Nose, Throat |
ESD |
874.3300 |
1 |
Y |
| HEARING-AID, BONE-CONDUCTION |
Ear, Nose, Throat |
LXB |
874.3300 |
2 |
N |
| HEARING-AID, BONE-CONDUCTION, IMPLANTED |
Ear, Nose, Throat |
MAH |
874.3300 |
2 |
N |
| HEARING-AID, GROUP AND AUDITORY TRAINER |
Ear, Nose, Throat |
EPF |
874.3320 |
2 |
N |
| HEARING-AID, MASTER |
Ear, Nose, Throat |
KHL |
874.3330 |
2 |
N |
| HEARING-AID, TACTILE |
Ear, Nose, Throat |
LRA |
|
|
N |
| HEART-VALVE, MECHANICAL |
Cardiovascular |
LWQ |
|
3 |
N |
| HEART-VALVE, REPLACEMENT |
Cardiovascular |
DYE |
870.3925 |
3 |
N |
| HEAT SOURCE FOR BLEACHING TEETH |
Dental |
EEG |
872.6475 |
1 |
Y |
| HEAT-EXCHANGER, CARDIOPULMONARY BYPASS |
Cardiovascular |
DTR |
870.4240 |
2 |
N |
| HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER |
Anesthesiology |
BZE |
868.5270 |
2 |
N |
| HEATER, PERINEAL, DIRECT CONTACT |
Obstetrics/Gynecology |
HGZ |
884.5390 |
2 |
N |
| HEATER, PERINEAL, RADIANT, NON-CONTACT |
Obstetrics/Gynecology |
HHA |
884.5390 |
2 |
N |
| HEAVY METALS CONTROL MATERIALS |
Clinical Toxicology |
DIE |
862.3280 |
1 |
N |
| HELMET, CRANIAL, FOR PROTECTIVE USE |
Physical Medicine |
NDA |
890.3025 |
1 |
Y |
| HELMET, SURGICAL |
General Plastic Surgery |
FXZ |
878.4040 |
1 |
Y |
| HEMAGGLUTINATION INHIBITION, BARBITURATE |
Clinical Toxicology |
DLX |
862.3150 |
2 |
N |
| HEMAGGLUTINATION INHIBITION, GENTAMICIN |
Clinical Toxicology |
DNO |
862.3450 |
2 |
N |
| HEMAGGLUTINATION INHIBITION, METHADONE |
Clinical Toxicology |
DIW |
862.3620 |
2 |
N |
| HEMAGGLUTINATION INHIBITION, MORPHINE |
Clinical Toxicology |
DLR |
862.3640 |
2 |
N |
| HEMAGGLUTINATION, COCAINE METABOLITES (BENZOYLECGNONINE) |
Clinical Toxicology |
DLN |
862.3250 |
2 |
N |
| HEMAGGLUTINATION, OPIATES |
Clinical Toxicology |
DLT |
862.3650 |
2 |
N |
| HEMATOCRIT, TUBE, RACK, SEALER, HOLDER |
Hematology |
GHY |
864.6400 |
2 |
Y |
| HEMATOXYLIN |
Pathology |
HYJ |
864.1850 |
1 |
Y |
| HEMATOXYLIN HARRIS'S |
Pathology |
HYK |
864.1850 |
1 |
Y |
| HEMATOXYLIN MAYER'S |
Pathology |
HYL |
864.1850 |
1 |
Y |
| HEMATOXYLIN WEIGERT'S |
Pathology |
HYO |
864.1850 |
1 |
Y |
| HEMATOXYLIN, ACID, PHOSPHOTUNGSTIC |
Pathology |
HZM |
864.1850 |
1 |
Y |
| HEMATOXYLIN, CHROME ALUM |
Pathology |
ICI |
864.1850 |
1 |
Y |
| HEMATOXYLIN, EHRLICH'S |
Pathology |
KKT |
864.1850 |
1 |
Y |
| HEMATOXYLIN, IRON, WEIGERT'S |
Pathology |
IAE |
864.1850 |
1 |
Y |
| HEMOCYTOMETER |
Hematology |
GHO |
864.6160 |
1 |
Y |
| HEMODIALYZER, RE-USE, HIGH FLUX |
Gastroenterology/Urology |
MSF |
876.5860 |
2 |
N |
| HEMODIALYZER, RE-USE, LOW FLUX |
Gastroenterology/Urology |
MSE |
876.5820 |
2 |
N |
| HEMOGLOBIN A2 QUANTITATION |
Hematology |
JPD |
864.7400 |
2 |
N |
| HEMOGLOBIN C (ABNORMAL HEMOGLOBIN VARIANT) |
Hematology |
MLL |
864.7415 |
2 |
N |
| HEMOGLOBIN F QUANTITATION |
Hematology |
JPC |
864.7455 |
2 |
N |
| HEMOGLOBIN M |
Hematology |
JPB |
864.7415 |
2 |
N |
| HEMOGLOBIN S |
Hematology |
GIQ |
864.7415 |
2 |
N |
| HEMOGLOBIN, ALKALI RESISTANT |
Hematology |
GHA |
864.7455 |
2 |
N |
| HEMOGLOBIN, CHAIN SPECIFIC, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DAM |
866.5470 |
2 |
Y |
| HEMOGLOBINOMETER |
Hematology |
GIG |
864.7500 |
2 |
N |
| HEMOPEXIN, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
CZX |
866.5490 |
2 |
Y |
| HEMOPEXIN, FITC, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
CZT |
866.5490 |
2 |
Y |
| HEMOPEXIN, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
CZR |
866.5490 |
2 |
Y |
| HEMOSTAT |
General Plastic Surgery |
HRQ |
878.4800 |
1 |
Y |
| HEMOSTAT, SURGICAL |
Dental |
EMD |
872.4565 |
1 |
Y |
| HEPARIN |
Pathology |
IAZ |
864.4400 |
1 |
Y |
| HEPARIN COATING CHEMICALS |
Cardiovascular |
LIS |
|
|
N |
| HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) |
Microbiology |
LOL |
|
3 |
N |
| HEPATITIS DELTA SEROLOGICAL REAGENTS |
Microbiology |
LQI |
|
3 |
N |
| HEXANE EXTRACTION, FLUORESCENCE, VITAMIN E |
Clinical Chemistry |
JOB |
862.1815 |
1 |
Y |
| HEXOKINASE, GLUCOSE |
Clinical Chemistry |
CFR |
862.1345 |
2 |
N |
| HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE |
Clinical Toxicology |
MGS |
862.1235 |
2 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, BARBITURATE |
Clinical Toxicology |
KZY |
862.3150 |
2 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, BENZODIAZIPINE |
Clinical Toxicology |
LAA |
862.3170 |
2 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, COCAINE AND COCAINE METABOLITES |
Clinical Toxicology |
LAC |
862.3250 |
2 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, CODEINE |
Clinical Toxicology |
LAE |
862.3270 |
2 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, METHAMPHETAMINE |
Clinical Toxicology |
LAG |
862.3610 |
2 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, OPIATES |
Clinical Toxicology |
LAH |
862.3650 |
2 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, PROPOXYPHENE |
Clinical Toxicology |
LAK |
862.3700 |
2 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, QUININE |
Clinical Toxicology |
LAM |
862.3750 |
1 |
N |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY, TRICYCLIC ANTIDEPRESSANT DRUGS |
Clinical Toxicology |
LFI |
862.3910 |
2 |
N |
| HILL HOLDER, WHEELCHAIR |
Physical Medicine |
INA |
890.3920 |
1 |
Y |
| HOE, PERIODONTIC |
Dental |
EMQ |
872.4565 |
1 |
Y |
| HOLDER, CAMERA, SURGICAL |
General Plastic Surgery |
FXR |
878.4160 |
1 |
Y |
| HOLDER, CRUTCH AND CANE, WHEELCHAIR |
Physical Medicine |
IMZ |
890.3910 |
1 |
Y |
| HOLDER, EAR SPECULUM |
General Plastic Surgery |
JYK |
878.1800 |
1 |
Y |
| HOLDER, FILM, X-RAY |
Dental |
EGZ |
872.1905 |
1 |
Y |
| HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) |
Neurology |
HBL |
882.4460 |
2 |
N |
| HOLDER, HEAD, RADIOGRAPHIC |
Radiology |
IWY |
892.1920 |
1 |
Y |
| HOLDER, HEART-VALVE, PROSTHESIS |
Cardiovascular |
DTJ |
870.3935 |
1 |
Y |
| HOLDER, INFANT POSITION |
General Hospital |
FRP |
880.5680 |
1 |
N |
| HOLDER, NEEDLE, GASTROENTEROLOGIC |
Gastroenterology/Urology |
FHQ |
876.4730 |
1 |
Y |
| HOLDER, NEEDLE; ORTHOPEDIC |
Orthopedic |
HXK |
888.4540 |
1 |
Y |
| HOLDER, RADIOGRAPHIC CASSETTE, WALL-MOUNTED |
Radiology |
IXY |
892.1880 |
1 |
Y |
| HOLDER, SPECULUM, ENT |
General Plastic Surgery |
KAG |
878.1800 |
1 |
Y |
| HOLDER, SYRINGE, LEAD |
Radiology |
IWR |
892.6500 |
1 |
Y |
| HOLDER, URETERAL CATHETER |
Gastroenterology/Urology |
EYJ |
876.5130 |
1 |
Y |
| HOLOGRAPH, FETAL, ACOUSTICAL |
Obstetrics/Gynecology |
HHX |
884.2225 |
2 |
N |
| HOME UTERINE ACTIVITY MONITOR |
Obstetrics/Gynecology |
LQK |
884.2730 |
2 |
N |
| HOOD, OXYGEN, INFANT |
Anesthesiology |
FOG |
868.5700 |
1 |
Y |
| HOOD, SURGICAL |
General Plastic Surgery |
FXY |
878.4040 |
2 |
N |
| HOOK, BONE |
General Plastic Surgery |
KIK |
878.4800 |
1 |
Y |
| HOOK, DESTRUCTIVE, OBSTETRICAL |
Obstetrics/Gynecology |
HDI |
884.4500 |
2 |
N |
| HOOK, ETHER |
Anesthesiology |
BTB |
868.5420 |
1 |
Y |
| HOOK, EXTERNAL LIMB COMPONENT, MECHANICAL |
Physical Medicine |
IQX |
890.3420 |
1 |
Y |
| HOOK, EXTERNAL LIMB COMPONENT, POWERED |
Physical Medicine |
IQW |
890.3420 |
1 |
Y |
| HOOK, FIBROID, GYNECOLOGICAL |
Obstetrics/Gynecology |
HDE |
884.4520 |
1 |
Y |
| HOOK, GASTRO-UROLOGY |
Gastroenterology/Urology |
FHB |
876.4730 |
1 |
Y |
| HOOK, MICROSURGICAL EAR |
Ear, Nose, Throat |
JYL |
874.4420 |
1 |
Y |
| HOOK, OPHTHALMIC |
Opthalmic |
HNQ |
886.4350 |
1 |
Y |
| HOOK, SURGICAL, GENERAL & PLASTIC SURGERY |
General Plastic Surgery |
GDG |
878.4800 |
1 |
Y |
| HOOK, TONSIL SUTURING |
Ear, Nose, Throat |
KBP |
874.4420 |
1 |
Y |
| HOOK, TRACHEAL |
Ear, Nose, Throat |
KCH |
874.4420 |
1 |
Y |
| HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE) |
Anesthesiology |
KFZ |
868.5460 |
1 |
Y |
| HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) |
Anesthesiology |
BTT |
868.5450 |
2 |
N |
| HYALURONIDASE |
Pathology |
IBD |
864.4400 |
1 |
Y |
| HYDRAZONE COLORIMETRY, ALDOLASE |
Clinical Chemistry |
CJT |
862.1040 |
1 |
Y |
| HYDRAZONE COLORIMETRY, ALT/SGPT |
Clinical Chemistry |
CKD |
862.1030 |
1 |
Y |
| HYDRAZONE COLORIMETRY, AST/SGOT |
Clinical Chemistry |
CIS |
862.1100 |
2 |
N |
| HYDRAZONE DERIV. OF ALPHA-KETOGLUTERATE (COLORIMETRY), ISOCITRIC DEHYDROGEN |
Clinical Chemistry |
JKH |
862.1420 |
1 |
Y |
| HYSTEROSCOPE (AND ACCESSORIES) |
Obstetrics/Gynecology |
HIH |
884.1690 |
2 |
N |
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