Atlas FDA

1991

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

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RecordFirmDate
BARD(R) BIOPOTENTIAL AMPLIFIER II (K913875)Bard Electrophysiology1991-11-27
MEDICAL TAPE (K912623)Renfrew Tape, Ltd.1991-11-27
INFINITY(TM) MICROTAPER HIP SYSTEM (K913874)Dow Corning Wright1991-11-27
VESSEL DILATOR (K913027)Deseret Medical, Inc.1991-11-27
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION (K914116)Medtronic Vascular1991-11-27
NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE (K914048)Baxter Healthcare Corp1991-11-27
HICOR (K914313)Siemens Gammasonics, Inc.1991-11-27
ENTREE NEEDLE (K914426)Core Dynamics, Inc.1991-11-27
UNIVERSAL GENERAL USE KIT #7-510-16 (K914401)Northgate Technologies, Inc.1991-11-27
BARD SINGULAR BIOPSY FORCEPS (K914212)C.R. Bard, Inc.1991-11-27
RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM (K913869)Siemens Medical Solutions USA, Inc.1991-11-25
FLOSWITCH(R) HP (K913871)Boston Scientific Corp1991-11-25
TX 3 TENS MODIFIED (K913532)Globalcare/Bay Medical Corp.1991-11-22
ICON COMPUTER SYSTEM (K914350)Siemens Gammasonics, Inc.1991-11-22
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER (K913305)Unipath , Ltd.1991-11-22
OLYMPUS FLEXIBLE TIP THORACOSCOPE (K913829)Olympus Corp.1991-11-22
ULTIMA XS, MODIFICATION (K912289)American Imex1991-11-22
PHILIPS RIGID VOLUME COILS (K911872)Philips Medical Systems, Inc.1991-11-22
RECORD AND VERIFY MEVATRON ADAPTER (K913674)Computerized Medical Systems, Inc.1991-11-22
3M IGE SINGLE POINT FAST TEST (K913212)Whittaker Bioproducts, Inc.1991-11-22
LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM (K914547)Baxter Healthcare Corp1991-11-22
OTOSONIC ACS-ASP (K914939)Beltone Electronics Corp.1991-11-22
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR (K914750)Roche Diagnostic Systems, Inc.1991-11-22
SHARP ENDOKNOT PUSHER (K914967)Sharpe Endosurgical Corp.1991-11-22
CVM (K914619)Ciba Corning Diagnostics Corp.1991-11-22
ITC GUIDING CATHETER (K913052)Interventional Therapeutics Corp.1991-11-22
SMITH AND DAVIS PRESSURE THERAPY SYSTEM (K913654)Smith & Davis Mfg. Co.1991-11-22
TARGET THERAPEUTICS RADIOPAQUE STYLET (K914001)Target Therapeutics1991-11-22
INCUBATOR 8000 SC (K914134)National Draeger, Inc.1991-11-22
MICROAIR 3500 (K914674)Gsi Development Co.1991-11-22
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES (K914460)Medtronic Vascular1991-11-22
MRH-500 (K911993)Hitachi Medical Systems America, Inc.1991-11-22
CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR (K914101)Circon Video1991-11-22
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 (K914018)Em Diagnostic Systems, Inc.1991-11-22
I-125 SEEDS, CODE: 6711 (K914281)Medi-Physics Inc. Dba Nycomed Amersham Imaging1991-11-22
DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY) (K914526)Davol, Inc.1991-11-22
BELTONE CLEARVOICE (K914940)Beltone Electronics Corp.1991-11-22
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS (K914263)Hitachi Medical Systems America, Inc.1991-11-22
IMMULITE DIGOXIN (K914833)Cirrus Diagnostics, Inc.1991-11-22
DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED (K914602)The Heart Valve Div. Medtronic Cardiovascular Surg1991-11-22
I-125 SEEDS IN CARRIER, CODE: 6720 (K914268)Medi-Physics Inc. Dba Nycomed Amersham Imaging1991-11-22
INCUBATOR 8000 IC (K913394)Dragerwerk AG1991-11-22
UROTEST GPH (K912244)In Wha Pharmaceutical Co., Ltd.1991-11-22
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 (K913921)Em Diagnostic Systems, Inc.1991-11-22
PERCUTANEOUS DILATOR WITH SHEATH (K913932)Interventional Therapeutics Corp.1991-11-22
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION (K913996)Siemens Medical Solutions USA, Inc.1991-11-22
ALLERGY INFORMATION MANAGER (K912294)Diagnostic Products Corp.1991-11-22
CORDIS OBTURATOR (K914352)Cordis Corp.1991-11-22
EASY ACCESS BED (K911893)Willis Therapeutic Innovations, Inc.1991-11-22
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS (K913830)Scimed Life Systems, Inc.1991-11-22
CEQUAL(TM) (K914527)General Electric Co.1991-11-22
TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS (K913633)Intermedics Orthopedics1991-11-22
PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM (K911782)Strato Medical Corp.1991-11-22
OSTEO BONE SCREWS (K913269)Fred C. Bryson1991-11-22
MAKAR MINI CANNULATED CANCELLOUS SCREWS (K912021)Instrument Makar, Inc.1991-11-22
TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) (K914025)Technicon Instruments Corp.1991-11-22
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT (K912764)Medtronic Vascular1991-11-22
TOWNLEY GREAT TOE JOINT (K911378)Biopro, Inc.1991-11-22
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR (K914225)E.I. Dupont DE Nemours & Co., Inc.1991-11-22
PRC AUTOPSY DEVICE (K913536)Pennstate1991-11-22
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM) (K914170)Bio-Rad1991-11-22
WHEELCHARIOT LIGHTWEIGHT MANUAL WHEELCHAIR (K914785)Wheelchariots, Inc.1991-11-22
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS (K914312)Scimed Life Systems, Inc.1991-11-22
MEDTRONIC 3625 SCREENER SYSTEM (K913442)Medtronic Vascular1991-11-22
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES (K913812)Osteonics Corp.1991-11-22
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 (K914464)Em Diagnostic Systems, Inc.1991-11-22
CATH CONTROL (K914211)Highpoint Medical Corp.1991-11-22
SUPRAPUBIC FLOW CONTROLLER (K904798)Olympus Corp.1991-11-22
ACE OPEN-BACK HALO RING (K914858)Ace Medical Co.1991-11-21
EXTERNAL GASTROSTOMY TUBE RETAINER (K912575)Sandoz Nutrition1991-11-21
SNAP-LOCK MICRO PORT, MODIFICATION (K910448)Infusaid Corp.1991-11-21
CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP (K914015)Pilling Co.1991-11-21
HYSTEROFLATOR 1500 (K911844)F.M. Wiest USA, Inc.1991-11-21
KLEER(TM) ORTHODONTIC BRACKET (K914616)Ormco Corp.1991-11-20
HEART NEBULIZER FLOWMETER ADAPTOR (K913015)B&B Medical Technologies, Inc.1991-11-20
INTERPRET(TM) CATHETER LINEAR TRANSLATOR (K913763)Intertherapy, Inc.1991-11-20
KTP/532 AND KTP/YAG (K913758)Laserscope1991-11-20
SIMPEX INC. SURGICAL DRESSING (K913794)Simpex, Inc.1991-11-20
DTF-1000LL,DTF-1000 (K911118)Cp Medical1991-11-20
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER (K913805)Pace Medical1991-11-19
PRESSURE GUARD (K913772)Beacon Laboratories, Inc.1991-11-19
QUANTA LITE(TM) ACA (K911680)Inova Diagnostics, Inc.1991-11-19
ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK (K914226)E.I. Dupont DE Nemours & Co., Inc.1991-11-19
ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP (K914358)Hobbs Medical, Inc.1991-11-19
SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT (K913928)Surgitek Medical Engineering Corp.1991-11-19
STATVIEW (K913755)Image Systems, Inc.1991-11-19
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) (K911795)Breg, Inc.1991-11-19
MARLOW SUCTION/IRRIGATION PROBES (K914872)Marlo Surgical Technology1991-11-19
SR1 FREE T4 ENZYME IMMUNOASSAY (K912937)Serono-Baker Diagnostics, Inc.1991-11-19
SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (K913427)Creative Laboratory Products, Inc.1991-11-19
INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER (K912600)Intertherapy, Inc.1991-11-19
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL (K914806)Roche Diagnostic Systems, Inc.1991-11-19
RELIEF BAND (T.E.N.S. DEVICE) (K901704)Maven Labs, Inc.1991-11-19
CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY (K914510)Beckman Instruments, Inc.1991-11-19
CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111 (K912516)Continental X-Ray Corp.1991-11-19
MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS (K911111)Vermont Diamond Instruments1991-11-19
TRACE GAMMA GT-SS REAGENT (K914731)Trace Scientific , Ltd.1991-11-19
HMS-5000 (K914085)Vitalog Monitoring,Inc.1991-11-19
ES1600 PARAMEDIC TELEPHONE (K912281)Epic Systems, Inc.1991-11-19
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG (K913827)Hewlett-Packard Co.1991-11-19
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Every clearance here is in the API, with alerts when new ones post.