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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
RIONET HEARING AID HB-69C (K802053)Rion Acoustic Instruments, Inc.1980-09-26
ETHICON RETRACTION TAPE (K801699)ETHICON, Inc.1980-09-26
BR 2002 X-RAY GENERATOR SYSTEM (K801808)Valmet Indus. Mach. & Prod., Inc.1980-09-26
LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (K801909)J.T. Baker Chemical Co.1980-09-26
GABBAY-FRATER SUTURE GUIDE (K802093)Howmedica Corp.1980-09-26
TENDER-SORB DRAIN SPONGES (K802225)Kendall Research Center1980-09-26
MICRO-FLOW SPECTROPHOTOMETER CL-720 (K801957)Shimadzu Precision Instruments, Inc.1980-09-26
BALLOON RETENTION CHEST CATHETER (K802025)Loseff Medical Designers, Ltd.1980-09-26
3M HI-STRENGTH MED. TAPE #1534 (K802242)3M Company1980-09-26
SHERWOOD VENTILATORY MUSCLE TRAINER (K802165)Sherwood Medical Co.1980-09-26
API-CTS STREPTOCOCCUS (K801951)Analytical Products, Inc.1980-09-26
RHYTIDOMETER (K801939)Aztec Medical Products, Inc.1980-09-26
MICROLAB M-MICROPROCESSOR DILUTER/DISP (K801913)Hamilton Co.1980-09-26
ARIA II 125- I-ESTRIOL SYSTEM (K801735)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-09-16
WAKO HDL CHOLESTEROL TEST (K801834)Wako Pure Chemical Industries, Ltd.1980-09-16
PROFILE SWAB CAT.#5273 & 5274 (K802004)Pollak (Intl.), Ltd.1980-09-16
C-SPLINT (K802104)Cutter Laboratories, Inc.1980-09-16
EYE APPLICATORS CAT.#980-983 (K802016)Pollak (Intl.), Ltd.1980-09-16
LACTI-QUANT (K801849)Nuclear Medical Laboratories, Inc.1980-09-16
BLEPHAROMETER (K801937)Aztec Medical Products, Inc.1980-09-16
WAKO TRIGLYCERIDE-G TEST (K801891)Wako Pure Chemical Industries, Ltd.1980-09-16
DEKNATEL GOOSEN VASCULAR PUNCH BLADES (K802079)Howmedica Corp.1980-09-16
DIMENSION I REFRACTION SYSTEM (K801767)Smr1980-09-16
FIRST AID BANDAGE CAT.#198 OR 199 (K802013)Pollak (Intl.), Ltd.1980-09-16
PLASTIC FORCEPS CAT.#1001-1010 (K801991)Pollak (Intl.), Ltd.1980-09-16
SUTURE REMOVAL SET CAT.#906 (K802019)Pollak (Intl.), Ltd.1980-09-16
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A (K801866)Pentax Precision Instrument Corp.1980-09-16
GUAZE BANDAGES CAT.#101-169 (K801996)Pollak (Intl.), Ltd.1980-09-16
MUELLER STRETCH M TAPE (K802073)Mueller Chemical Co.1980-09-16
FENZL RETICLE (K801733)Robert E. Fenzl, M.D.1980-09-16
SPINAL FLUID CONTROL(HUMAN) (K801854)Environmental Chemical Specialties1980-09-16
PEDIBAND CAT.#195-197 (K802021)Pollak (Intl.), Ltd.1980-09-16
DATA-ZYME LAT(GPT) PROCEDURE (K801857)Data Medical Associates, Inc.1980-09-16
BACITRACIN DIFFERENTIATION DISC (K802127)Biomedia, Inc.1980-09-16
TRIANGULAR BANDAGE CAT.#191 (K802006)Pollak (Intl.), Ltd.1980-09-16
STREP B POLYVALENT FLUORO-KIT (K801876)Clinical Sciences, Inc.1980-09-16
BLOOD GLUCOSE TESTER (K801536)Broomer Research Corp.1980-09-16
CENTRIFICHEM PIPETTOR 1000 (K801851)Union Carbide Corp.1980-09-16
3390A REPORTING INTEGRATOR (K802031)Hewlett-Packard Co.1980-09-16
ALGESIOMETER (K801907)Rowan Products, Inc.1980-09-16
CORNING 60 VOLT POWER SUPPLY (K801893)Corning Medical & Scientific1980-09-16
C-BLADE (K802105)Cutter Laboratories, Inc.1980-09-16
OXYGEN SUPPLY TUBING (K802071)Auburn Components1980-09-16
ASSURE LEVEL I PROD. #30171 (K801538)Warner-Lambert Co.1980-09-09
SURGICAL BANDAGES/SUNLEEP DX (K801840)Martin'S Maine Exchange1980-09-09
URINE SPECIMEN CONTAINER #'S 1013-1016 (K802002)Pollak (Intl.), Ltd.1980-09-09
RHINOMETER (K801938)Aztec Medical Products, Inc.1980-09-09
FINGER PAINGUARD CAT.#193-194 (K802015)Pollak (Intl.), Ltd.1980-09-09
PEEP FACE MASK (K801883)Vital Signs, Inc.1980-09-09
SAPCRILL THERMODETECT BREAST SCANNER DEV (K801573)California Cardiac Systems, Inc.1980-09-09
SPOR-TEST CULTURE MEDIA (K801980)Mdt Corp., Inc.1980-09-09
CAM-10 RESPIRATORY HOSE ASSEMBLIES (K801859)Lifecare Services, Inc.1980-09-09
ELASTIC BANDAGE CAT.#182-186 (WIDTH) (K801990)Pollak (Intl.), Ltd.1980-09-09
RIONET HEARING AID HB-70H (K801958)Rion Acoustic Instruments, Inc.1980-09-09
HDL CHOLESTEROL TEST KIT (K801726)Mallinckrodt Critical Care1980-09-09
CULSWAB CAT.#978 & 979 (K802023)Pollak (Intl.), Ltd.1980-09-09
LITTLE GIANT I & II HANDPIECE CONTROL (K801975)Silverman'S1980-09-09
ACE FISCHER EXTERNAL FIXATION DEVICE (K801594)Ace Orthopedic Manufacturing Co.1980-09-09
EYE PADS CAT.#581-599 (K801995)Pollak (Intl.), Ltd.1980-09-09
SOF-TOUCH NASAL CANNULA CAT.#304 & 305 (K802062)Hospitak, Inc.1980-09-09
BRAIN HEART INFUSION MICROBIOLOGICAL (K801943)Radiation Technology, Inc.1980-09-09
ASSURE LEVEL II PROD. #30172 (K801539)Warner-Lambert Co.1980-09-09
SUR-FIT SYSTEM STERILE O.R. SETS (K801703)E. R. Squibb & Sons, Inc.1980-09-09
PALPATION ENHANCER (K801811)Medical Horizons Co.1980-09-09
EMBOSSED DISP. POLY. GLOVES #5101-03 (K801997)Pollak (Intl.), Ltd.1980-09-09
STERILE EXAMINATION GLOVE #5121-5126 (K801998)Pollak (Intl.), Ltd.1980-09-09
PREP SET CAT.#908 (K802020)Pollak (Intl.), Ltd.1980-09-09
VOCON MODEL VC526 (K801314)Teknar, Inc.1980-09-09
FIELD-LEE BRAIN BIOPSY NEEDLE (K801760)American V. Mueller1980-09-09
HANCOCK * OBTURATORS (K801885)Hancock Laboratories, Inc.1980-09-09
TEST PANEL FOR PRESUMP. ID/BACT. ORG (K801547)Micro-Media Systems, Inc.1980-09-09
ASNIS GUIDED SCREW SYSTEMS (K801969)Howmedica Corp.1980-08-27
GAS-CHROMATOGRAPHIC PACKING (K801833)Supelco, Inc.1980-08-27
SUR-FIT SYSTEM PRE-OPERATION SET (K801702)E. R. Squibb & Sons, Inc.1980-08-27
PAD, EXAMINING TABLE (K801936)Volunteer Blind Industries, Inc.1980-08-27
HOWMEDICA BITE BLOCK (K801911)Howmedica Corp.1980-08-27
TESTOSTERONE KIT (K801666)Immuchem Corp.1980-08-27
MICROBIOLOGY CULTURE MEDIA, C.L.E.D. (K801817)Radiation Technology, Inc.1980-08-27
DIOPTRON III AUTOREFRACTOR (K801906)Coherent Medical Division1980-08-27
FLOTATION PAD FOR OPERATING TABLE (K801694)Action Products, Inc.1980-08-27
MODEL 9300 ELECTROCARDIOVALIDATOR (K801830)Del Mar Avionics1980-08-27
BURR, DENTAL (K801886)Aesculap Instruments Corp.1980-08-20
CORNING 184 BLOOD GAS TONOMETER (K801599)Corning Medical & Scientific1980-08-20
BAND-AID BRAND TRICOT MESH BANDAGES (K801823)Johnson & Johnson Professionals, Inc.1980-08-20
ENZYME-ASE I TUBES (K801915)Microchemical Specialities, Co.1980-08-20
PHOTOMETER LP 3 (K801563)Dr. Bruno Lange GmbH1980-08-20
BK-1499 KAY-KPLINT HAND CONE/BK-1500 (K801707)Fred Sammons, Inc.1980-08-20
PHOTOMETER LP 6 (K801562)Dr. Bruno Lange GmbH1980-08-20
HANDPIECE, DENTAL (K801888)Aesculap Instruments Corp.1980-08-20
SUTURE REMOVAL PAK (K801746)Devco Medical Industries, Inc.1980-08-20
ORNITH-ASE TUBES (K801916)Microchemical Specialities, Co.1980-08-20
BAND-AID BRAND FLEXIBLE FABRIC BANDAGE (K801824)Johnson & Johnson Professionals, Inc.1980-08-20
WALL MOUNTED LASER POSITIONING DEVICE (K801541)Advantage Medical Systems, Inc.1980-08-20
JACKSON-PRATT LARGE VOL. CLOSED WOUND (K801766)American Heyer Schulte1980-08-20
BMC RIAFLO SYSTEM (K801481)Boehringer Mannheim Corp.1980-08-20
VISTA 44 GAS CHROMATOGRAPHY ANALYSIS (K801745)Varian Assoc., Inc.1980-08-20
MAXI CAMERA 61 (K801654)General Electric Co.1980-08-20
SURGICAL INSTRUMENTS (K801819)Robert I. Chien & Assoc., Inc.1980-08-20
LEBODY BY WATER PIK (K801593)Teledyne, Inc.1980-08-20
DRILL, DENTAL (K801887)Aesculap Instruments Corp.1980-08-20
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Every clearance here is in the API, with alerts when new ones post.