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

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RecordFirmDate
BIOMERIEUX RSV DIRECT IF KIT (K912371)Vitek Systems, Inc.1991-09-23
SEVACARE STERILE SURGEON'S GLOVES (K912478)Sevaids Industries1991-09-23
MECHANICAL SHAPE SENSOR (K913510)Pin Dot Products, Inc.1991-09-23
QTEST INFLUENZA A (K913828)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-09-23
UC312, ULTRA MINIATURE ITC HEARING AID (K914017)Qualitone1991-09-23
ABBOTT QUICKSTART ALANINE AMINOTRANSFER (K913846)Em Diagnostic Systems, Inc.1991-09-19
BACTIDROP(TM) NITRATE A (K913011)Remel Co.1991-09-19
SURGICAL GOWN (K912790)Unicor Federal Dept. of Justice1991-09-19
BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE (K913243)Bennett X-Ray Corp.1991-09-19
NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (K911399)Aequitron Medical, Inc.1991-09-19
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 (K913922)Em Diagnostic Systems, Inc.1991-09-19
CHEM-CHEX (K913687)Streck Laboratories, Inc.1991-09-19
BACTIDROP (TM) NITRATE B (K913010)Remel Co.1991-09-19
SIME TRUFEEL (K913048)Sime Health, Ltd.1991-09-19
QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID (K913781)Qualitone1991-09-18
ELEGANCE - KED, BEHIND THE EAR HEARING AID (K913771)Qualitone1991-09-18
QUALITONE 46PP-AGC-I (K913592)Qualitone1991-09-18
BACTIDROP(TM) INDOLE (KOVACS) (K913009)Remel Co.1991-09-18
BACTIDROP(TM) DESOXYCHOLATE (10%) (K913001)Remel Co.1991-09-18
BACTIDROP(TM) SPOT INDOLE (K913004)Remel Co.1991-09-18
WHITER BITER CROWN (K912686)George M. Wilson, Dds1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 (K913062)Shimadzu Medical Systems1991-09-16
SATIN PROPHYLAXIS PASTE (K912945)Dentsply Intl.1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10 (K913063)Shimadzu Medical Systems1991-09-16
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST (K912442)Quidel Corp.1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L (K913064)Shimadzu Medical Systems1991-09-16
GULL ELISAWARE (K912558)Gull Laboratories, Inc.1991-09-16
TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL (K912696)Bennett X-Ray Corp.1991-09-16
TIN COATED DENTAL BURS (K911208)Surgical Precision Instruments, Corp.1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L (K913065)Shimadzu Medical Systems1991-09-16
AMB-ALERT (K911079)Medway1991-09-13
ATRIUMS PDR THORACIC CATHETER (K912645)Atrium Medical Corp.1991-09-13
TDM I LINEARITY TEST SET (K913309)Casco Standards1991-09-13
DENTAL NEEDLE PROTECTIVE SYSTEM (K910475)Health Technology Systems, Inc.1991-09-13
CORDLESS ELECTRIC MASSAGER EV315 (K912634)Matsushita Electric Co.1991-09-12
SLIP-PRUF-CLINGER (K913049)Macbrud Corp. Medical Div.1991-09-11
TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE (K913207)Baxter Healthcare Corp1991-09-11
FLOCARE DRY CAS SAMPLING PORT MODELS (K912700)Flocare Medical1991-09-11
IMX SELECT ANALYZER (K912368)Abbott Laboratories1991-09-11
OPUS(R) PLUS ANALYZER (K913295)Pb Diagnostic Systems, Inc.1991-09-11
CHOLINESTERASE LINEARITY CONTROL (K913496)Creative Laboratory Products, Inc.1991-09-11
FLOCARE LF-A (K912699)Flocare Medical1991-09-11
BARD(R) DISPOSABLE BIOPSY FORCEPS (K912549)C.R. Bard, Inc.1991-09-10
STRETCH GAUZE BANDAGE (K912954)Cal West Trading Co.1991-09-10
12-PLY GAUZE PAD (K912951)Cal West Trading Co.1991-09-10
SOUND RELIEF (K912659)Windmere Corp.1991-09-06
DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL (K913650)Duo Research, Inc.1991-09-06
ENZYME LINEARITY CONTROL (K912718)Phoenix Diagnostics, Inc.1991-09-06
PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT (K913503)Phonak, Inc.1991-09-06
TRIANGULAR BANDAGE,40 (K912949)Cal West Trading Co.1991-09-06
HYPOALLERGENIC SURGICAL LATEX GLOVES (K912157)Medigloves , Ltd.1991-09-06
SALIBAG (K913168)Nix Co. , Ltd.1991-09-06
PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT (K913502)Phonak, Inc.1991-09-06
TAICHI STICK MASSAGER (K912512)Focus International, Inc.1991-09-06
HYPOALLERGENIC EXAMINATION LATEX GLOVES (K912503)Medigloves , Ltd.1991-09-06
THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 (K913055)Atomic Products Corp.1991-09-06
ID-TAB (K913160)Nix Co. , Ltd.1991-09-06
PIN DOT ALUMINUM PAN (K913548)Pin Dot Products, Inc.1991-09-05
IMPALA AXLES (K913511)Pin Dot Products, Inc.1991-09-05
ARMREST (K913507)Pin Dot Products, Inc.1991-09-05
PIN DOT GROWTH/DIAL LINKS (K913553)Pin Dot Products, Inc.1991-09-05
PIN DOT TRUNION MOUNTS (K913550)Pin Dot Products, Inc.1991-09-05
PIN DOT MOUNTING BRACKETS (K913549)Pin Dot Products, Inc.1991-09-05
PIN DOT FLIP-DOWN ABDUCTOR (K913545)Pin Dot Products, Inc.1991-09-05
IMPALA CASTERS (K913546)Pin Dot Products, Inc.1991-09-05
IMPALA WHEELS (K913509)Pin Dot Products, Inc.1991-09-05
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE (K912518)Convatec, A Division of E.R. Squibb & Sons1991-09-04
AUGUSTINE GUIDE(TM) KIT (K912690)Augustine Medical, Inc.1991-09-04
KODAK EKTACHEM DTII SYSTEM (K912844)Eastman Kodak Company1991-09-04
ROSYS MODELS 100 AND 200 (K913664)Packard Instrument Co., Inc.1991-08-30
EYE ARTIFICIAL CUSTOM (K904962)Midwest Eye Laboratories, Inc.1991-08-30
KAPS 90 DEGREE FIBEROPTIC ADAPTOR (K912885)Jedmed Instrument Co.1991-08-30
METROLAB MODEL 1500 (K910806)Laboratorio Rodriguez Corswant S.R.L.1991-08-30
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN (K913229)Baxter Diagnostics, Inc.1991-08-29
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST (K912190)Stryker Corp.1991-08-29
IMPALA (K913512)Pin Dot Products, Inc.1991-08-29
DUKKI (K913544)Pin Dot Products, Inc.1991-08-29
PIN DOT FOOTREST PRODUCTS (K913552)Pin Dot Products, Inc.1991-08-29
EDENTEC DIGITAL CHARTER MODEL 3710 (K910871)Edentec Corp.1991-08-29
EYE TRAY (K912105)Medical Device Inspection Co., Inc.1991-08-29
ARTHROSCOPY TRAY (K912106)Medical Device Inspection Co., Inc.1991-08-29
VENTROFIL TENSION RELIEF SUTURE SET (K904435)Aesculap, Inc.1991-08-29
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET (K912439)Hybritech, Inc.1991-08-28
DENTAL CONNECTOR PRECISION ATTACHMENT (K912435)Metalor Dental USA Corp.1991-08-28
BONE MARROW BIOPSY TRAY (K912074)Manan Medical Products, Inc.1991-08-28
PROACT CHOLESTEROL SYSTEMS (K912212)Boehringer Mannheim Corp.1991-08-28
MICRO-X 15 HF (K912449)Fischer Imaging Corp.1991-08-28
THE SPRITZ BATH (K912179)The Spritz Co.1991-08-28
MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM (K913301)Comet North America, Inc.1991-08-28
FRAMES (EYE GLASSES) (K913046)Jiuh Chyi Ent. Co., Ltd.1991-08-28
KODAK EKTACHEM DT SLIDES (LAC) (K913197)Eastman Kodak Company1991-08-26
PHILIPS S1594 OTB HEARING AID (K913389)Philips Hearing Instruments Co.1991-08-26
DEVON SPONGE COUNTER BAGS (K912824)Devon Industries, Inc.1991-08-26
URINE COLLECTION KIT/DEVICE (K913330)Medical Implements, Inc.1991-08-26
KODAK EKTACHEM DT SLIDES (CHE) (K913198)Eastman Kodak Company1991-08-26
M32 IN-THE-EAR HEARING AID (K913390)Philips Hearing Instruments Co.1991-08-26
J105 JAMES SURGICAL SYSTEM I/A PACK (K911932)O.R. Specialties, Inc.1991-08-26
OPEN HEART TRAY (K912053)Medical Device Inspection Co., Inc.1991-08-26
ABUSCREEN(R) ONLINE(TM) CONTROLS (K913336)Roche Diagnostic Systems, Inc.1991-08-26
BBL(R) DMACA INDOLE REAGENT DROPPERS (K912480)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-08-23
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Every clearance here is in the API, with alerts when new ones post.