Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BARD UROTRACK II MONITORING (K924436)C.R. Bard, Inc.1994-03-15
TORQUE DEVICE (K936032)Merit Medical Systems, Inc.1994-03-15
ORION DIAGNOSTIC ULTRASOUND SYSTEM (K930768)GE Medical Systems1994-03-15
SLIMFLEX - POWDER FREE LATEX EXAMINATION GLOVES (K933224)Slim River Latex Sdn. Bhd.1994-03-15
PATIENT EXAMINATION GLOVE - POWDERED (K932332)Sj Medical Products (M) Sdn Bhd1994-03-15
OXISAT (K934091)Marquette Electronics, Inc.1994-03-15
VERSADOWEL POST SYSTEM (K940680)Dental Power, Inc.1994-03-15
SYNTHES UNREAMED HUMERAL NAIL (URHN) (K933518)Synthes (Usa)1994-03-14
TERRA FEMME (K930400)Bio Business Intl, Inc.1994-03-14
GAMMA LOCKING NAIL MODIFICATION (K940286)Howmedica, Inc.1994-03-14
HASKEL CPR (K922093)Haskel, Inc.1994-03-14
360 DEGREE FIXATION LIGHT (K933739)Varitronics1994-03-14
HI-FLO INFUSION PUMP (K934671)Abbott Laboratories1994-03-14
HOME MICROCURRENT HMC (K935132)Medical Devices, Inc.1994-03-14
CEDIA DAU NEGATIVE CALIBRATOR (K935793)Microgenics Corp.1994-03-14
PEGASUS (K925178)Premier Laser Systems, Inc.1994-03-14
HVGS 9000 (K926084)Shevlin Medical, Inc.1994-03-14
MXT-2 12 LEAD MICRO-TRANSMITTER (K933012)Medical Electronic Record Exchange1994-03-14
MAHE INSTRUMENTS (K935442)Mahe-Medizintechnik1994-03-14
NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS (K940463)Nonin Medical, Inc.1994-03-14
OPHTHALMIC SURGICAL SYSTEM (K935223)Optical Micro Systems, Inc.1994-03-14
SURGICAL INSTRUMENT, DISPOSABLE (K940684)Her-Mar, Inc.1994-03-14
MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE (K935814)Boston Scientific Corp1994-03-14
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB (K936028)Microgenics Corp.1994-03-14
SPORTS RADIO SUNGLASSES (K936027)Vast Lea Enterprise Co. , Ltd.1994-03-14
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (K936130)Roche Diagnostic Systems, Inc.1994-03-11
FLEXIBLE EXTENDER (K930243)Beacon Laboratories, Inc.1994-03-11
COOK LAPAROSCOPIC MINI RETRACTOR SET (K936026)Cook Urological, Inc.1994-03-11
ERYTHROPOIETIN IMMUNOASSAY KIT (K932650)Nichols Institute1994-03-11
GLOVE SEAL, POWDER FREE LATEX EXAMINATION GLOVES (K934316)Contract Latex Dippers Sdn Bhd1994-03-11
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS (K935904)Microgenics Corp.1994-03-11
URINARY ALBUMIN CALIBRATOR (K936201)Dupont Medical Products1994-03-11
DISPOSIBLE ELECTRO COAGULATION PROBE (K924057)Endoscopic Technologies, Inc.1994-03-11
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR (K934843)E.I. Dupont DE Nemours & Co., Inc.1994-03-11
CREATININE-S ASSAY (K934587)Diagnostic Chemicals , Ltd.1994-03-11
INFANT WARMER (K931529)Medix I.C.S.A.1994-03-11
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS (K935568)Baxter Diagnostics, Inc.1994-03-11
COULTER MULTI Q PREP (K935953)Coulter Corp.1994-03-11
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (K936131)Roche Diagnostic Systems, Inc.1994-03-11
DANNIFLEX CPM 600 (K933394)Danninger Medical Technology, Inc.1994-03-11
TYTIN (K935535)Kerr Corporation (Danbury)1994-03-11
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST (K924715)Gen-Probe, Inc.1994-03-11
ARTHREX TIBIAL TUNNEL CANNULA (K930152)Arthrex, Inc.1994-03-11
CYTOLOGY BRUSH (K933628)Bioteque America, Inc.1994-03-11
DMA AMYLASE (DEMAND) PROCEDURE (K940010)Data Medical Associates, Inc.1994-03-11
ACCESS SPECIFIC IGE ASSAY (K935876)Bio-Rad Laboratories, Inc.1994-03-11
VALPROIC ACID (K936208)Seradyn, Inc.1994-03-11
YOKE ASSEMBLY MEDICAL GAS (K935283)American Gage & Medical, Inc.1994-03-11
ENDOPATH RELOADABLE LINEAR CUTTER (K930934)ETHICON, Inc.1994-03-11
BIP-COAX-SYSTEM (K915801)Uni-Quatro Industries Canada, Inc.1994-03-11
FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (K915857)Olympus Corp.1994-03-11
EEC PROBE (K935115)Phx Technologies Corp.1994-03-11
FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST (K931557)Fuller Laboratories, Inc.1994-03-11
ACS O DILVENT PROTEIN DILUTION MATRIX (K940397)Analytical Control Systems, Inc.1994-03-11
COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT. (K931900)Archival Technologies, Inc.1994-03-11
SEPP ADHESIVE REMOVER (K934790)Medi-Flex Hospital Products, Inc.1994-03-11
SHIELDTEX STERILE PATIENT EXAMINATION GLOVES (K940387)Shieldtex Sdn Bhd1994-03-11
RETRACTORS AND SCRAPER (K933008)Baxter Healthcare Corp1994-03-11
SIGMA CALCIUM REAGENT (K933678)Sigma Chemical Co.1994-03-11
ORTHOPEDIC TRAY PRODUCT LINE (K940646)Cushindu1994-03-11
GC FUJI COAT LC (K935961)GC America, Inc.1994-03-10
SYNTHES STERILE PINLESS EXTERNAL FIXATOR (K925460)Synthes (Usa)1994-03-10
PROFORM HIP SYSTEM (K934161)Stelkast Company1994-03-10
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM (K926395)Depuy, Inc.1994-03-10
VIFI: VECTOR INTERFERENTIAL ONE (K931732)Compliance Technology, Inc.1994-03-10
ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL (K932593)Synthes (Usa)1994-03-10
STERILE WATER (K933526)Trinity Laboratories, Inc.1994-03-10
STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER (K940130)Stryker Corp.1994-03-10
CATHETER INSERTION TRAY (K936261)Medcare Custom Packaging, Inc.1994-03-10
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM (K932519)Osteonics Corp.1994-03-10
STRYKER PRECISION DENTAL IMPLANT SYSTEM (K921805)Stryker Instruments1994-03-10
SNAP STERNUM SAW (K935517)Surgiquip, Inc.1994-03-10
MICROTRACK (K935929)Devices For Vascular Intervention, Inc.1994-03-10
RMHS POROUS DISTAL SLEEVE (K932574)Smith & Nephew Richards, Inc.1994-03-10
E 4000 DENTAL OPERATING CHAIR (K925567)Dentalez Group1994-03-10
LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) (K936048)Cogent Light Technologies, Inc.1994-03-10
SUTTER PROXIMAL INTERPHALANGEAL JOINT (K931588)Sutter Corp.1994-03-10
AESCULAP SKIN GRAFT MESHER (K936186)Aesculap, Inc.1994-03-10
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP (K935905)Scimed Life Systems, Inc.1994-03-10
VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER (K925485)Vas-Cath, Inc.1994-03-10
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW (K932862)Smith and Nephew Donjoy, Inc.1994-03-10
PELVIC C-CLAMP (K922796)Synthes (Usa)1994-03-10
ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM (K934044)Smith and Nephew Donjoy, Inc.1994-03-10
NEW GEAR RELEASABLE HEADGEAR (K940410)Ortho Kinetics Corp.1994-03-10
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) (K925345)Biomet, Inc.1994-03-10
TECNOL SPLASHGUARD (K934842)Tecnol Medical Products, Inc.1994-03-09
PROFORM HA HIP SYSTEM (K934162)Stelkast Company1994-03-09
LASSO (SCHWAITZBERG) SUTURE SNARE (K934737)Performance Surgical Instruments Corp.1994-03-09
S-ROM TOTAL HIP REPLACEMENT SYSTEM (K935078)Joint Medical Products Corp.1994-03-09
HM-880 I (K932817)Hill-Med, Inc.1994-03-09
FX-CABLELOK CABLE/PLATE SYSTEM (K935950)Buckman Co., Inc.1994-03-09
REAGENTS FOR HITACHI ISE (K933383)Alko Diagnostic Corp.1994-03-09
CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM (K940171)Cabot Medical Corp.1994-03-09
ERBOTOM ICC 350 (K933002)Erbe USA, Inc.1994-03-09
POWDER FREE LATEX EXAMINATION GLOVES (K933810)Clydesdale Industries Sdn. Bhd.1994-03-09
REPLICA(TM) TOTAL HIP SYSTEM (K926156)Osteo Technology, Inc.1994-03-09
PATIENT EXAMINATION GLOVES (K935256)Comfort Rubber Gloves Industries Sdn. Bhd.1994-03-09
SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60 (K926543)Sharplan Lasers, Inc.1994-03-09
MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST (K924258)Ceram Optec, Inc.1994-03-09
DUKAL NON-WOVEN GAUZE (K940440)Dukal Corp.1994-03-09
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Track 1994 automatically

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