Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LOW POROSITY (LP) VASCULAR PROSTHESIS (K912911)Intervascular, Inc.1991-09-23
DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES (K913012)Eigen1991-09-23
ETUDE (MODEL NUMBERS 24A05 & 24A06) (K913323)Dantec Medical, Inc.1991-09-23
UC312, ULTRA MINIATURE ITC HEARING AID (K914017)Qualitone1991-09-23
LM-100/200LOW FLOW INSUFFLATOR (K912789)Leisegang Medical, Inc.1991-09-20
GALIX MA-6C HOLTER CASSETTE RECORDER (K904177)Galix Instrumentacion Biomedica1991-09-20
GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER (K904176)Galix Instrumentacion Biomedica1991-09-20
CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER (K912777)Cordis Corp.1991-09-20
COLLIMASTER-90 (K911127)Varian Assoc., Inc.1991-09-19
ABBOTT QUICKSTART ALANINE AMINOTRANSFER (K913846)Em Diagnostic Systems, Inc.1991-09-19
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS (K912087)Instrumentation Laboratory CO1991-09-19
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM (K912974)Elscint, Inc.1991-09-19
FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-9110 (K912515)Continental X-Ray Corp.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
TROCAR (FALLER STYLET) (K910786)Accurate Surgical Instruments Co.1991-09-19
XIMATRON/CT OPTION (K910647)Fischer Imaging Corp.1991-09-19
SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100 (K913147)Shimadzu Medical Systems1991-09-19
NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (K911399)Aequitron Medical, Inc.1991-09-19
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS (K913123)Syva Co.1991-09-19
AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE (K912927)Intl. Medical, Inc.1991-09-19
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (K913867)Immunalysis Corporation1991-09-19
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 (K913922)Em Diagnostic Systems, Inc.1991-09-19
AUTO SUTURE ENDOSCOPIC FASCIA STAPLER (K912097)United States Surgical, A Division of Tyco Healthc1991-09-19
NGM GAS MODULE (K911647)Datex Division Instrumentarium Corp.1991-09-19
CHEM-CHEX (K913687)Streck Laboratories, Inc.1991-09-19
SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL (K911312)Northgate Technologies, Inc.1991-09-19
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE (K912005)Codman & Shurtleff, Inc.1991-09-19
VISTA HPQ SYSTEM (K913534)Philips Medical Systems (Cleveland), Inc.1991-09-19
FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109 (K912517)Continental X-Ray Corp.1991-09-19
FURUI SHUNT, 2-WAY AND 3-WAY (K910004)Theramed, Inc.1991-09-19
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (K913863)Immunalysis Corporation1991-09-19
BACTIDROP (TM) NITRATE B (K913010)Remel Co.1991-09-19
SIME TRUFEEL (K913048)Sime Health, Ltd.1991-09-19
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (K911912)Serono-Baker Diagnostics, Inc.1991-09-18
LEMAITRE-BOOKWALTER VESSEL DEVICES (K912548)Vascutech, Inc.1991-09-18
QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID (K913781)Qualitone1991-09-18
LM-300TWIN (K913135)Leisegang Medical, Inc.1991-09-18
URINE THC DIRECT RIA KIT (I-125) (K913865)Immunalysis Corporation1991-09-18
PLASTIC ATTACHABLE DUAL PORT (K912702)Davol, Inc.1991-09-18
UTAH ESSU (K905263)Utah Medical Products, Inc.1991-09-18
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD (K912235)Intermedics, Inc.1991-09-18
ELEGANCE - KED, BEHIND THE EAR HEARING AID (K913771)Qualitone1991-09-18
PRO-GUIDE (K911747)American Interventional Technology1991-09-18
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
ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTS (K912614)Andrew Surgical1991-09-18
BACTIDROP(TM) SPOT INDOLE (K913004)Remel Co.1991-09-18
HIGH SPEED MAGNETIC STIMULATOR (K905059)Cadwell Laboratories, Inc.1991-09-18
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28 (K913707)Em Diagnostic Systems, Inc.1991-09-18
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (CLS) (K912793)Surgical Laser Technologies, Inc.1991-09-18
PALMER ARCH SUPPRESSOR (K913347)Smith & Nephew Dyonics, Inc.1991-09-18
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR (K905747)Coopervision Surgical1991-09-17
RICH-MAR MODEL 25 ULTRASOUND (K912202)Rich-Mar Corp.1991-09-17
ECHOMARK CSI INTERFACE (K910965)Catheter Sciences Co.1991-09-17
HEARING CHECKER(TM), DESKTOP MODEL (K904622)Qualitone Hearing Aids and Audiometers1991-09-17
MEDI-KLEER (K904871)North American Marketing Corp.1991-09-17
CLASSIC 4-WAY ELEVATING TABLE (K912474)Continental X-Ray Corp.1991-09-16
MED-E-JET INJECTOR (K913018)Med-E-Jet D1991-09-16
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE (K913005)Remel Co.1991-09-16
WHITER BITER CROWN (K912686)George M. Wilson, Dds1991-09-16
NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT (K912663)Intermedics Orthopedics1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 (K913062)Shimadzu Medical Systems1991-09-16
5MM MICROSCISSORS (K913870)Endovations1991-09-16
SATIN PROPHYLAXIS PASTE (K912945)Dentsply Intl.1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10 (K913063)Shimadzu Medical Systems1991-09-16
CORDIS INFLATOR DEVICE (K912644)Cordis Corp.1991-09-16
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST (K912442)Quidel Corp.1991-09-16
ADVANCE DISPOSABLE CONTROL SYRINGE (K911732)Advance Medical Designs, Inc.1991-09-16
HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE (K913564)Heraeus Lasersonics, Inc.1991-09-16
MEDRAD VARIBLE INFUSION INJECTOR (K905819)Medrad, Inc.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
THE BULLION (K910757)Octostop, Inc.1991-09-16
TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL (K912696)Bennett X-Ray Corp.1991-09-16
EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS (K913410)Syva Co.1991-09-16
STERILE SURGICAL GOWN PACK (K911131)Central Georgia Ancillary Health Systems1991-09-16
TIN COATED DENTAL BURS (K911208)Surgical Precision Instruments, Corp.1991-09-16
ENDOSCOPIC ELECTRODE (K912656)Applied Urology, Inc.1991-09-16
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE (K911433)Cordis Corp.1991-09-16
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM (K912669)Resound Corp.1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L (K913065)Shimadzu Medical Systems1991-09-16
LEG URINAL (K913155)Ezmt Valve Co., Inc.1991-09-16
MINIMAX OXYGENATION SYSTEM (K912655)Medtronic Vascular1991-09-13
AIR ARGON ION LASERS VARIOUS MODELS (K912628)Hgm Medical Laser Systems, Inc.1991-09-13
INTHERM RADIALLY EXPANDING DILATER (K912971)Interventional Therapeutics Corp.1991-09-13
CONTROL AND LINEARITY (K910881)Gds Diagnostics1991-09-13
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION (K913154)Ohmeda Medical1991-09-13
ICAN NEEDLE COUNTERS (K913446)Icn Pharmaceuticals, Inc.1991-09-13
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
URINARY/CSF PROTEIN (K913615)Boehringer Mannheim Corp.1991-09-13
DIPSTICK SALMONELLA (K910438)Ampcor, Inc.1991-09-13
DENTAL NEEDLE PROTECTIVE SYSTEM (K910475)Health Technology Systems, Inc.1991-09-13
SAFETY INJECTION PORT, MODIFICATION (K913311)Riverside Technology, Inc.1991-09-13
SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER (K911626)Serono Baker Diagnostics System1991-09-13
X-L (DW228-14A) AND X-LX (DW228-24A) (K913070)Ivoclar North America, Inc.1991-09-13
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Track 1991 automatically

Every clearance here is in the API, with alerts when new ones post.