Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST (K904782)Carter Products1990-12-06
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL (K904829)Analytical Control Systems, Inc.1990-12-06
SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM (K904171)Scimed1990-12-06
QCLYTE PROTEIN BASED ISE CONTROL (K904968)Baxter Healthcare Corp1990-12-06
GUIDEWIRE (K904477)Datascope Corp.1990-12-06
CLINICAL CHEMISTRY CONTROL (K904075)Phoenix Diagnostics, Inc.1990-12-06
SITE PHACOEMULSIFICATION HANDPIECE (K904183)Site Microsurgical Systems, Inc.1990-12-05
DENE BRIDGE (K903672)Dirotian Pty. , Ltd.1990-12-05
SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE (K904151)Site Microsurgical Systems, Inc.1990-12-05
STERI-VAC(TM) AERATOR MODEL XL (K904921)3M Health Care, Ltd.1990-12-05
37-702 AND 37-703 PC RAINBOW (K900932)Victoreen, Inc.1990-12-05
MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA (K904050)Philips Medical Systems (Cleveland), Inc.1990-12-05
LYSTA HYGIENIST III SCALER (K904296)Prodent Intl., Inc.1990-12-05
HORIZON REGULAR ETCHING GEL (K904199)Horizon Chemical Co.1990-12-05
TSRH OFFSET AND SIDE-LOADING HOOKS (K903461)Danek Medical, Inc.1990-12-05
ADVANCE DISPOSABLE STOPCOCK (K902724)Advance Medical Designs, Inc.1990-12-05
MICROMED QRS CARD (K903722)Nasiff Assoc., Inc.1990-12-05
DPX-L AND DPX-ALPHA, MODIFICATION (K904980)Lunar1990-12-05
ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR (K904104)ETHICON, Inc.1990-12-05
VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH (K903417)Vas-Cath, Inc.1990-12-05
PROXIMAL FEMUR REPLACEMENT STEM (K904919)Depuy, Inc.1990-12-05
CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM (K904417)Device Labs, Inc.1990-12-05
GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS (K904142)Baxter Healthcare Corp1990-12-05
MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (K900464)Medical Innovations Corp.1990-12-05
DISPOSABLE EMISSIONS BARRIER LASER DRAPE (K903346)Wave-Form Systems, Inc.1990-12-05
EYE PAD (K904896)Ulti-Med Intl., Inc.1990-12-05
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES (K904844)Howmedica Corp.1990-12-05
ARTHROSCOPIC SURGICAL BLADE (K904284)Smith & Nephew Dyonics, Inc.1990-12-05
SINGLE LUMEN CATHETER KITS (K904139)Akcess Medical Products, Inc.1990-12-04
RUBEOLA IGG ELISA TEST (K904854)Gull Laboratories, Inc.1990-12-04
RUBELLA IGM ELISA TEST (K904084)Gull Laboratories, Inc.1990-12-04
IMPRAFLO 3500 SERIES (K904515)Impra, Inc.1990-12-04
ORTHO RUBELLA-M ANTIBODY ELISA TEST (K905079)Ortho Diagnostic Systems, Inc.1990-12-04
P AND T MEDIUM (K904773)Gibson Laboratories, Inc.1990-12-04
SPORTS RIDER AND SHOP RIDER (K905245)National Health Services, Inc.1990-12-04
FLEXISYS (K904149)Dornier Medtech America, Inc.1990-12-04
COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY (K904101)Kendall Healthcare Products Co. Div.Of Tyco Health1990-12-04
NEURITOR 2001 (K902752)Imexco General , Ltd.1990-12-04
TRANSTAT-CMV(TM) (K903308)Ab Sangtec Medical1990-12-04
MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE (K903921)Imt America, Inc.1990-12-04
ICOR HCH 4, ICOR HCH 7 (K904338)Icor AB1990-12-04
PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 (K904986)Perkins Mfg. Co.1990-12-04
LATEX EXAMINATION GLOVES (K902796)Ek Hong Rubber Industry (Thailand) Co., Ltd.1990-12-04
VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (K903882)Viral Antigens, Inc.1990-12-04
HIGH-PRESSURE CONNECTOR TUBE (K904212)Mallinckrodt Medical1990-12-03
CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS (K902475)Cardio-Pak1990-12-03
AMPLATZ GOOSE-NECK SNARE (K901502)Microvena Corp.1990-12-03
OCHSNER 50 BIFURCATION (K903964)Intervascular, Inc.1990-12-03
DISPOSABLE INFLATION GAUGE (K902695)Cook Urological, Inc.1990-12-03
OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER (K902367)Vas-Cath, Inc.1990-12-03
GENTLE HEADER (K902845)Enhanced Perfusion Systems, Inc.1990-12-03
MODEL #210 STEALTH DEFIB PADS (K904462)Cardiotronics, Inc.1990-12-03
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES (K905086)Hpi, Inc.1990-12-03
INFLATION/DEFLATION DEVICE (K904394)Boston Scientific Corp1990-12-03
CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT (K902612)Cordis Corp.1990-12-03
PERCUTANEOUS INTRODUCER TRAY (K904608)Thomas Medical Products, Inc.1990-12-03
SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH (K902587)Schneider Intl., Ltd.1990-12-03
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH. (K902317)Mallinckrodt Medical1990-12-03
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE (K900560)Acuson Corp.1990-12-03
MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002 (K903018)Medtronic Andover Medical, Inc.1990-12-03
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM (K896437)Kontron Instruments, Inc.1990-12-03
FLAGEN TM FREE T4 (K904539)Cyberfluor, Inc.1990-11-30
CURITY NERVE BLOCK TRAY (K903887)Kendall Healthcare Products Co. Div.Of Tyco Health1990-11-30
JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT (K901147)Joslyn Valve Corp.1990-11-30
CONTINUOUS VOLUME VENTILATOR MODEL LP10 (K903010)Aequitron Medical, Inc.1990-11-30
A-1107 ABUTMENT (FIXED) (K903041)Minimatic Implant Technology1990-11-30
MODEL LP6 VENTILATOR, MODIFICATION (K905244)Aequitron Medical, Inc.1990-11-30
KXO-80C/80D (K904043)Toshiba America Medical Systems, In.C1990-11-29
COROMETRICS MODEL 556 NEONATAL MONITOR (K900001)Ge Medical Systems Information Technologies1990-11-29
HEMOCHRON(R) HEPARIN RESPONSE TEST (K904003)Intensive Technology, Inc.1990-11-29
BIORE CP-100 CARDIOPULMONARY MONITOR (K900696)Bicore Monitoring Systems1990-11-29
CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A (K903372)Shimadzu Medical Systems1990-11-29
ECONOMY C-ARM TABLE, MODEL # 056-005 (K904187)Atomic Products Corp.1990-11-29
RUBBER LATEX SURGICAL GLOVES, STERILE (K905161)Rfb Latex Pvt. , Ltd.1990-11-29
ELEGANCE FERRITIN ELISA (K904822)Bioclone Australia Pty , Ltd.1990-11-29
JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR (K902157)Johnson & Johnson Medical, Inc.1990-11-29
IVT RAST TRACER (K904661)In Vitro Technologies, Inc.1990-11-29
CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY (K902647)Kendall Healthcare Products Co. Div.Of Tyco Health1990-11-29
FLOCARE (K904193)Flocare Medical1990-11-29
FLEXI-TRAK(TM) ANCHORING DEVICE (K905128)Convatec, A Division of E.R. Squibb & Sons1990-11-29
JAIN GRAFT ASSIST (K904536)Jain Surgical Equipment, Inc.1990-11-29
HUESTIS FLEXI-BOARD (K904005)Huestis Machine Corp.1990-11-29
CATHETERIZATION C-ARM SUPPORT MH-51C(F) (K903373)Shimadzu Medical Systems1990-11-29
CATHETERIZATION C-ARM SUPPORT MH-51B(F) (K903371)Shimadzu Medical Systems1990-11-29
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV (K901536)Depuy, Inc.1990-11-29
TF-63SA (K904044)Toshiba America Medical Systems, In.C1990-11-29
STAT.BR TM (K904482)Kerr Corporation (Danbury)1990-11-29
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE (K903358)Advance Medical Designs, Inc.1990-11-29
PHILIPS INTEGRIS I 2000 SYSTEM (K904012)Philips Medical Systems, Inc.1990-11-29
ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY (K904158)Welcon, Inc.1990-11-29
EMIT (R) II PHENCYCLIDINE ASSAY (K904765)Syva Co.1990-11-28
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (K904995)Roche Diagnostic Systems, Inc.1990-11-28
BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT (K904184)Biotron U.S.A., Inc.1990-11-28
TORQUE FRAME QTF1000 (K904898)Medmetric Corp.1990-11-28
NORPLANT(R) TROCAR (K903490)Wyeth-Ayerst Laboratories, Inc.1990-11-28
HYCOR ACCUPINCH METHAMPHETAMINE TEST (K904115)Hycor Biomedical, Inc.1990-11-28
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 (K905096)Amresco, Inc.1990-11-28
STRATUS PRIMIDONE FLUOROMETRIC ENZYME (K904683)Baxter Healthcare Corp1990-11-28
EZ-SCREEN:BARBITURATES (K905057)Environmental Diagnostics, Inc.1990-11-28
SECONDARY CALIBRATORS (K904698)Bionostics, Inc.1990-11-28
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Track 1990 automatically

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