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FDA Product Classification Codes Begining with "B"


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FDA Device Classification Medical Specialty FDA Product Code FDA Regulation Number Device Class 510k Exempt?
BACILLUS SUBTLIS MICROBIOLOGY ASSAY, TOBRAMYCIN Clinical Toxicology DID 862.3900 2 N
BACILLUS SUBTLIS, MICROBIOLOGICAL ASSAY, GENTAMICIN Clinical Toxicology DKD 862.3450 2 N
BAG, BILE COLLECTING Gastroenterology/Urology EXF 876.5010 2 N
BAG, DRAINAGE, WITH ADHESIVE, OSTOMY Gastroenterology/Urology FON 876.5900 1 Y
BAG, HEMOSTATIC Gastroenterology/Urology FCB 876.5980 2 N
BAG, ICE General Hospital KYR 880.6050 1 Y
BAG, INTESTINE General Plastic Surgery KGY 878.4100 1 Y
BAG, POLYMERIC MESH, PACEMAKER Cardiovascular DSW 870.3650 1 Y
BAG, RESERVOIR Anesthesiology BTC 868.5320 1 Y
BAG, STOMAL Gastroenterology/Urology GDS 876.5900 1 Y
BAG, URINARY, ILEOSTOMY Gastroenterology/Urology EXH 876.5900 1 Y
BAG, URINE COLLECTING, URETEROSTOMY Gastroenterology/Urology EXG 876.5900 1 Y
BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE Gastroenterology/Urology NNW 876.5250 1 Y
BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE Gastroenterology/Urology FAQ 876.5250 1 Y
BAG, URINE COLLECTION, NEWBORN Gastroenterology/Urology FOC 876.5250 2 Y
BALANCE, ANALYTICAL Clinical Chemistry JQO 862.2050 1 Y
BALLISTOCARDIOGRAPH Cardiovascular DXR 870.2320 2 N
BALLOON, EPISTAXIS Ear, Nose, Throat EMX 874.4100 1 Y
BALLOON, HEATED, PERIPHERAL ANGIOPLASTY Cardiovascular MKF 3 N
BALLOON, LIVER TAMPONADE General Plastic Surgery NGU 876.5980 2 N
BALLOON, MIDDLE EAR Ear, Nose, Throat MGL 3 N
BALLOON,DETACHABLE,FOR NEUROVASCULAR OCCLUSION Neurology MZQ 882.5950 3 N
BAND OR BELT, PELVIC SUPPORT Physical Medicine ISR 890.3025 1 Y
BAND, ELASTIC, ORTHODONTIC Dental ECI 872.5410 1 Y
BAND, MATERIAL, ORTHODONTIC Dental DYO 872.5410 1 Y
BAND, PREFORMED, ORTHODONTIC Dental ECM 872.5410 1 Y
BAND, TUBAL OCCLUSION Obstetrics/Gynecology HFY 884.5380 3 N
BANDAGE, CAST Physical Medicine ITG 890.3025 1 Y
BANDAGE, ELASTIC General Hospital FQM 880.5075 1 Y
BANDAGE, LIQUID General Plastic Surgery KMF 880.5090 1 N
BAR, PREFORMED Dental EHO 872.3165 1 Y
BARRIER, ABSORABLE, ADHESION Obstetrics/Gynecology MCN 3 N
BARRIER, CONTROL PANEL, X-RAY, MOVABLE Radiology IWX 892.6500 1 Y
BARRIER,STD,ORAL SEX Obstetrics/Gynecology MSC N
BARS, PARALLEL, EXERCISE Physical Medicine IOE 890.5370 1 Y
BARS, PARALLEL, POWERED Physical Medicine IRR 890.5380 1 Y
BASIC FUCHSIN Pathology KKW 864.1850 1 Y
BASIN, EMESIS General Hospital FNY 880.6730 1 Y
BATH, FLOTATION, TISSUE Pathology IDY 864.3010 1 Y
BATH, HYDRO-MASSAGE Physical Medicine ILJ 890.5100 2 N
BATH, INCUBATORS/WATER, ALL Microbiology JTQ 866.2540 1 Y
BATH, PARAFFIN Physical Medicine IMC 890.5110 2 N
BATH, SITZ, NONPOWERED Physical Medicine KTC 890.5125 1 Y
BATH, SITZ, POWERED Physical Medicine ILM 890.5100 2 N
BATH, STERILIZER General Plastic Surgery LZZ N
BATHOPHENANTHROLINE, COLORIMETRY, IRON (NON-HEME) Clinical Chemistry CFM 862.1410 1 N
BATHOPHENANTHROLINE, IRON BINDING CAPACITY Clinical Chemistry JQF 862.1415 1 N
BATTERIES, RECHARGEABLE, CLASS I DEVICES Cardiovascular MOW N
BATTERIES, RECHARGEABLE, CLASS II DEVICES Cardiovascular MOX N
BATTERIES, RECHARGEABLE, CLASS III Cardiovascular MOY 3 N
BATTERY, PACEMAKER Cardiovascular DSZ 870.3610 3 N
BATTERY, REPLACEMENT, RECHARGEABLE General Plastic Surgery MOQ 878.4820 1 Y
BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION General Plastic Surgery KOZ 878.4018 1 Y
BED, AC-POWERED ADJUSTABLE HOSPITAL General Hospital FNL 880.5100 2 Y
BED, AIR FLUIDIZED Physical Medicine INX 890.5160 2 Y
BED, FLOTATION THERAPY, POWERED Physical Medicine IOQ 890.5170 2 Y
BED, HYDRAULIC, ADJUSTABLE HOSPITAL General Hospital FNK 880.5110 1 Y
BED, MANUAL General Hospital FNJ 880.5120 1 Y
BED, PATIENT ROTATION, MANUAL Physical Medicine INY 890.5180 1 Y
BED, PATIENT ROTATION, POWERED Physical Medicine IKZ 890.5225 2 Y
BED, PEDIATRIC OPEN HOSPITAL General Hospital FMS 880.5140 2 Y
BED, ROCKING, BREATHING ASSIST Anesthesiology CCO 868.5180 2 N
BED, SCANNING, NUCLEAR Radiology IYZ 892.1350 1 Y
BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE General Hospital LLI N
BEDDING, DISPOSABLE, MEDICAL General Hospital KME 880.6060 1 Y
BEDPAN General Hospital FOB 880.6730 1 Y
BELL, CIRCUMCISION Obstetrics/Gynecology FHG 884.4530 2 Y
BELT, PELVIC, TRACTION Orthopedic HSQ 888.5890 1 Y
BELT, WHEELCHAIR Physical Medicine IQB 890.3920 1 Y
BENCE-JONES PROTEIN, ANTIGEN, ANTISERUM, CONTROL Immunology CZQ 866.5150 2 N
BENDER Orthopedic HXW 888.4540 1 Y
BERTHELOT INDOPHENOL, UREA NITROGEN Clinical Chemistry CDL 862.1770 2 N
BEST'S CARMINE Pathology ICO 864.1850 1 Y
BETA GLYCEROPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES Clinical Chemistry CJL 862.1050 2 N
BETA-2-GLYCOPROTEIN I, ANTIGEN, ANTISERUM, CONTROL Immunology DDN 866.5430 1 Y
BETA-2-GLYCOPROTEIN III, ANTIGEN, ANTISERUM, CONTROL Immunology DDK 866.5440 1 Y
BETA-D-FRUCTOSE & NADH OXIDATION (U.V.), SORBITOL DEHYDROGENASE Clinical Chemistry JNK 862.1670 1 Y
BETA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROL Immunology DCJ 866.5160 1 Y
BETATRON, MEDICAL Radiology IYG 892.5050 2 N
BIEBRICH SCARLET Pathology ICN 864.1850 1 Y
BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM Clinical Chemistry MQM 862.1113 1 N
BINDER, ABDOMINAL General Hospital FSD 880.5160 1 Y
BINDER, BREAST General Hospital HEF 880.5160 1 Y
BINDER, ELASTIC General Hospital KMO 880.5160 1 Y
BINDER, MEDICAL, THERAPEUTIC General Hospital MDR 880.5160 1 Y
BINDER, PERINEAL General Hospital FQK 880.5160 1 Y
BIOMICROSCOPE, SLIT-LAMP, AC-POWERED Opthalmic HJO 886.1850 2 N
BIOSENSOR, IMMUNOASSAY, CPK OR ISOENZYMES Clinical Chemistry MYT 862.1215 2 N
BIOSENSOR,IMMUNOASSAY,MYOGLOBIN Immunology MVE 866.5680 2 N
BIOSPY DEVICE, PERCUTANEOUS, REPROCESSED General Plastic Surgery NNA 878.4800 1 N
BISMARCK BROWN Y Pathology KJM 864.1850 1 Y
BISTOURY, TRACHEAL Ear, Nose, Throat KCC 874.4420 1 Y
BIT, DRILL Orthopedic HTW 888.4540 1 Y
BIT, SURGICAL General Plastic Surgery GFG 878.4820 1 Y
BIURET (COLORIMETRIC), TOTAL PROTEIN Clinical Chemistry CEK 862.1635 2 Y
BLADE, KERATOME, REPROCESSED Opthalmic NKY 886.4370 1 N
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL General Plastic Surgery GFA 878.4820 1 Y
BLADE, SAW, SURGICAL, CARDIOVASCULAR General Plastic Surgery DWH 878.4820 1 Y
BLADE, SCALPEL General Plastic Surgery GES 878.4800 1 Y
BLANKET, FIRE General Hospital LDI N
BLENDER, SPUTUM Pathology IHJ 864.3010 1 Y
BLENDER/MIXER Clinical Chemistry JRO 862.2050 1 Y
BLOCK, BEAM-SHAPING, RADIATION THERAPY Radiology IXI 892.5710 2 N
BLOCK, BITE Neurology JXL 882.5070 2 N
BLOCK, CUTTING, ENT, NON-STERILE Ear, Nose, Throat NNR 874.3540 1 Y
BLOCK, CUTTING, ENT, STERILE Ear, Nose, Throat JXS 874.3540 1 Y
BLOCK, HEATING Clinical Chemistry JRG 862.2050 1 Y
BLOCK, TEST, ULTRASONIC SCANNER CALIBRATION Neurology GXX 882.1925 1 Y
BLOOD, OCCULT, COLORIMETRIC, IN URINE Hematology JIO 864.6550 2 N
BLOOD, OCCULT, ENZYMATIC METHOD, IN URINE Hematology JIP 864.6550 2 N
BOARD, ARM (WITH COVER), STERILE General Plastic Surgery BTX 878.3910 1 Y
BOARD, ARM (WTIH COVER), NON-STERILE General Plastic Surgery NOD 1 Y
BOARD, BED General Hospital FPS 880.6070 1 Y
BOARD, CARDIOPULMONARY General Hospital FOA 880.6080 1 Y
BOARD, LAP, WHEELCHAIR Physical Medicine IMX 890.3910 1 Y
BOARD, SCOOTER, PRONE Physical Medicine KNL 890.5370 1 Y
BONE ANALYZER, SONIC, NON-INVASIVE Orthopedic MHH 3 N
BONE CEMENT Orthopedic LOD 888.3027 2 N
BONE FILLING AUGMENTATION MATERIAL Dental LYC N
BONE MILL Orthopedic LYS N
BONE PARTICLE COLLECTOR Ear, Nose, Throat MXP 874.4800 1 Y
BONE SONOMETER Radiology MUA 3 N
BOOTH, SUN TAN General Plastic Surgery LEJ 878.4635 1 Y
BOTHROPS ATROX REAGENT Hematology JCO 864.8100 2 N
BOTTLE, BLOW Anesthesiology BYO 868.5220 1 Y
BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED) General Hospital CBC 880.6740 2 Y
BOTTLE, COLLECTION, BREATHING SYSTEM (CALIBRATED) General Hospital CBD 880.6740 2 Y
BOTTLE, COLLECTION, VACUUM General Hospital KDQ 880.6740 2 Y
BOTTLE, HOT/COLD WATER General Hospital FPF 880.6085 1 Y
BOTTLE, ROLLER, TISSUE CULTURE Pathology KJC 864.2240 1 Y
BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY Gastroenterology/Urology FAT 876.5365 2 N
BOUGIE, ESOPHAGEAL, ENT Ear, Nose, Throat KCD 874.4420 1 Y
BOUGIE, EUSTACHIAN Ear, Nose, Throat KBI 874.4175 1 Y
BOUGIE, UROLOGICAL Gastroenterology/Urology FAX 876.5520 1 Y
BOX, BATTERY, POCKET Gastroenterology/Urology FCP 876.1500 1 Y
BOX, BATTERY, RECHARGEABLE Gastroenterology/Urology FCO 876.1500 1 Y
BOX, GLOVE, ANAEROBIC Microbiology JTM 866.2120 1 Y
BOXES, VIEW, BLOOD GROUPING Hematology KSY 864.9185 1 Y
BRACE, DRILL Orthopedic HXY 888.4540 1 Y
BRACKET, CERAMIC, ORTHODONTIC Dental NJM 872.5470 2 N
BRACKET, METAL, ORTHODONTIC Dental EJF 872.5410 1 Y
BRACKET, PLASTIC, ORTHODONTIC Dental DYW 872.5470 2 N
BRACKET, PLASTIC, ORTHODONTIC, REPROCESSED Dental NLC 872.5470 2 N
BRAKE, EXTENSION, WHEELCHAIR Physical Medicine IMW 890.3920 1 Y
BREAST MILK, ANTIGEN, ANTISERUM, CONTROL Immunology DGM 866.5170 1 Y
BREAST MILK, FITC, ANTIGEN, ANTISERUM, CONTROL Immunology DGN 866.5170 1 Y
BREAST MILK, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL Immunology DGI 866.5170 1 Y
BRILLIANT CRESYL BLUE Pathology KJN 864.1850 1 Y
BRILLIANT GREEN Pathology KJO 864.1850 1 Y
BRILLIANT YELLOW Pathology ICM 864.1850 1 Y
BROACH Orthopedic HTQ 888.4540 1 Y
BROACH, ENDODONTIC Dental EKW 872.4565 1 Y
BROMCRESOL GREEN DYE-BINDING, ALBUMIN Clinical Chemistry CIX 862.1035 2 N
BROMCRESOL PURPLE DYE-BINDING, ALBUMIN Clinical Chemistry CJW 862.1035 2 N
BRONCHOSCOPE (FLEXIBLE OR RIGID) Ear, Nose, Throat EOQ 874.4680 2 N
BRONCHOSCOPE ACCESSORY Ear, Nose, Throat KTI 874.4680 2 N
BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) Ear, Nose, Throat BTG 874.4680 2 N
BRUSH, BIOPSY, GENERAL & PLASTIC SURGERY General Plastic Surgery GEE 878.4800 1 Y
BRUSH, CLEANING, TRACHEAL TUBE Anesthesiology EPE 868.5795 1 Y
BRUSH, CYTOLOGY, FOR ENDOSCOPE Gastroenterology/Urology FDX 876.1500 2 N
BRUSH, DERMABRASION, MANUAL General Plastic Surgery GED 878.4800 1 Y
BRUSH, DERMABRASION, POWERED General Plastic Surgery GFE 878.4820 1 Y
BRUSH, ENDOMETRIAL Obstetrics/Gynecology HFE 884.1100 2 N
BRUSH, HAIDINGER, (INCLUDING MACULAR INTEGRITY) Opthalmic HIY 886.1090 1 Y
BRUSH, SCRUB, OPERATING-ROOM General Plastic Surgery GEC 878.4800 1 Y
BULB, INFLATION, FOR ENDOSCOPE Gastroenterology/Urology FCY 876.1500 1 Y
BUR Ear, Nose, Throat EQJ 874.4140 1 Y
BUR, DENTAL Dental EJL 872.3240 1 Y
BUR, DIAMOND COATED, REPROCESSED Dental NME 872.3240 1 N
BUR, ENT, DIAMOND COATED, SINGLE USE, REPROCESSED Ear, Nose, Throat NLZ 874.4140 1 N
BUR, SURGICAL, GENERAL & PLASTIC SURGERY General Plastic Surgery GFF 878.4820 1 Y
BURNISHER, OPERATIVE Dental EKJ 872.4565 1 Y
BURR Orthopedic HTT 888.4540 1 Y
BURR, CORNEAL, AC-POWERED Opthalmic HQS 886.4070 1 N
BURR, CORNEAL, BATTERY-POWERED Opthalmic HOG 886.4070 1 N
BURR, CORNEAL, MANUAL Opthalmic HOF 886.4350 1 Y
BUTTON, IRIS, EYE, ARTIFICIAL Opthalmic NCK 886.3200 1 Y
BUTTON, NASAL SEPTAL Ear, Nose, Throat LFB N


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