Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
OSTEOLOCK ACETABULAR CUP (K981201)Howmedica Corp.1998-05-29
GEEN MEDISOX (K981296)Geen Healthcare, Inc.1998-05-29
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES (K980780)Datascope Corp.1998-05-29
BABYTHERM 8000 LDR (K980886)Draeger Medical, Inc.1998-05-29
ETEST CHLORAMPHENICAL (K980342)Ab Biodisk1998-05-29
J-FX BIPOLAR HEAD (K980801)Johnson & Johnson Professionals, Inc.1998-05-29
MICRO-STRIP FOR COCAINE METABOLITES (K981388)Microdiagnostics, Inc.1998-05-29
PEDIATRIC PRC (K981113)Acromed Corp.1998-05-29
B-D AUTO-INJECTOR (K974678)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-05-29
DISPOSABLE RE-NEW FORCEPS (K981389)Microline Pentax, Inc.1998-05-29
UROSURGE FILASTENT URETERAL STENT (K981491)Urosurge, Inc.1998-05-29
ETEST VANCOMYCIN (K980348)Ab Biodisk1998-05-29
VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM (K981700)Origin Medsystems, Inc.1998-05-29
CREATININE (CREA) (K981240)Abbott Laboratories1998-05-29
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND (DEN980001)Cranial Technologies, Inc.1998-05-29
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES (K980994)Venetec Intl., Inc.1998-05-29
STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL (K974771)Stryker Endoscopy1998-05-29
UROSURGE SPIRASTENT PLUS URETERAL STENT (K981489)Urosurge, Inc.1998-05-29
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 (K981512)Skd, Inc. A Beckman Coulter Co.1998-05-28
LYSONIX LIPOPLASTY ACCESS PORT (K980763)Lysonix, Inc.1998-05-28
LICEMEISTER COMB (K981250)National Pediculosis Assoc.1998-05-28
ETEST TETRACYCLINE (K981134)Ab Biodisk1998-05-28
ETEST OFLOXACIN (K980338)Ab Biodisk1998-05-28
CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. (K980961)Cordis Webster, Inc.1998-05-28
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (K972849)Cypress Medical Products, Ltd.1998-05-28
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT (K974285)Perimed, Inc.1998-05-28
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES (K980992)Venetec Intl., Inc.1998-05-28
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 (K972502)Spacelabs Medical, Inc.1998-05-28
SURGISIS (K980431)Cook Biotech, Inc.1998-05-28
AIA-PACK MYOGLOBIN ASSAY (K981012)Tosoh Medics, Inc.1998-05-28
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) (K981585)Roche Diagnostic Systems, Inc.1998-05-28
PAINBUSTER INFUSION SYSTEM (K980558)I-Flow Corp.1998-05-28
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) (K981584)Roche Diagnostic Systems, Inc.1998-05-28
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING (K980989)Innovative Technologies , Ltd.1998-05-27
ETEST TETRACYCLINE (K980347)Ab Biodisk1998-05-27
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (K981607)Diagnostic Systems Laboratories, Inc.1998-05-27
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM (K981626)Siemens Medical Solutions USA, Inc.1998-05-27
ETEST CEFTRIAXONE (K980345)Ab Biodisk1998-05-27
OSTEONICS ANTEVERTED NECK HA HIP STEMS (K980766)Osteonics Corp.1998-05-27
ALBG (K981468)Abbott Laboratories1998-05-27
HOPE NEBULIZER (K980407)B&B Medical Technologies, Inc.1998-05-27
ALBP (K981457)Abbott Mfg., Inc.1998-05-27
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR (K980917)Fortune Medical Instrument Corp.1998-05-27
ALKPHASE-B ASSAY KIT (K981373)Metra Biosystems, Inc.1998-05-27
SIMAL CERVICAL STABILIZATION SYSTEM (K981008)Top Surgical Products GmbH1998-05-27
MANAN GENERAL UTILITY DRAINAGE CATHETER (K980193)Medical Device Technologies, Inc.1998-05-27
MANAN NEPHROSTOMY DRAINAGE CATHETER (K980192)Medical Device Technologies, Inc.1998-05-27
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) (K981206)Cardiovascular Diagnostics, Inc.1998-05-26
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER (K973545)Vacumed, Div. of Vacumetrics, Inc.1998-05-26
DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL (K981043)Solution Technologies1998-05-26
IL TEST PLASMINOGEN (K981200)Instrumentation Laboratory CO1998-05-26
AIRPREP SYSTEM - MODEL 9001 (K974488)Asi Medical, Inc.1998-05-26
INTRAVASCULAR RETRIEVAL DEVICE (K981061)Med Institute, Inc.1998-05-26
DIMERTEST LATEX ASSAY (K974596)Agen Biomedical , Ltd.1998-05-26
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD (K973360)Medtronic Vascular1998-05-26
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST (K981292)Syntron Bioresearch, Inc.1998-05-26
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK (K981099)Dade Behring, Inc.1998-05-26
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS (K980739)OraSure Technologies, Inc.1998-05-26
BRANEMARK SYSTEM DEC 600 DRILLING UNIT (K974123)Nobel Biocare Uas, Inc.1998-05-26
CEDIA DAU EDDP ASSAY (K980746)Boehringer Mannheim Corp.1998-05-26
VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER (K973544)Vacumed, Div. of Vacumetrics, Inc.1998-05-26
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) (K981341)OraSure Technologies, Inc.1998-05-22
SONOS 5500 ULTRASOUND IMAGING SYSTEM (K980687)Hewlett-Packard Co.1998-05-22
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION (K980858)Becton Dickinson Immunocytometry Systems1998-05-22
APR -T REVISION HIP STEM (K981211)Sulzer Orthopedics, Inc.1998-05-22
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM (K980710)Schwartz Electro-Optics, Inc.1998-05-22
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM (K980788)Alphatec Mfg., Inc.1998-05-22
CLEAR (TM) SPECIAL NIT COMB (K981037)Care Technologies, Inc.1998-05-22
DOWNSCAN LT (K974882)Merlin Engineering Works, Inc.1998-05-22
IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS (K980781)Implex Corp.1998-05-22
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI (K974245)Depuy Ace Medical Co.1998-05-22
ACCU-CHEK COMFORT CURVE TEST STRIPS (K980731)Boehringer Mannheim Corp.1998-05-22
CABLE SCREW WITH INTEGRAL CRIMP (K980690)Pioneer Surgical Technology1998-05-22
FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM (K980713)Howmedica Corp.1998-05-22
UROMED SLING KIT (K980717)Uromed Corp.1998-05-22
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS (K970968)Guenter Bissinger Medizintechnik GmbH1998-05-21
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) (K974695)Roche Diagnostic Systems, Inc.1998-05-21
SPYROSORB FOAM ISLAND WOUND DRESSING (K980673)Innovative Technologies (Us), Inc.1998-05-21
PLUS REUSABLE RESUSCITATOR (K974141)Schiff & Co.1998-05-21
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE (K974571)Baxter Healthcare Corp1998-05-21
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER (K973840)Daig Corp.1998-05-21
SPIGAL NEEDLE (K980676)Gallini U.S., LLC1998-05-21
FLEXIBLE FIBERSCOPES AND ACCESSORIES (K980401)Richard Wolf Medical Instruments Corp.1998-05-21
NEOCOLLOID, ORTHOPRINT (K981091)Zhermack S.P.A.1998-05-21
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM (K973929)Neotonus, Inc.1998-05-21
OSTEONICS LONG ARM CONTAINMENT RING (K981452)Osteonics Corp.1998-05-20
SIS HERNIA REPAIR DEVICE (K974540)Sentron Medical, Inc.1998-05-20
RADIOCAMERAS PATIENT POSITIONING SYSTEM (K980750)Surgical Navigation Technologies, Inc.1998-05-20
ULTRA BILI LIGHT (K974830)Physician Engineered Products, Inc.1998-05-20
COPPER TONGUE SCRAPER (K980842)Ontel Products Corp.1998-05-20
TITANIUM SPINAL ROD SYSTEM (K980862)United States Surgical, A Division of Tyco Healthc1998-05-20
DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL (K980861)Dumex Medical Surgical Products, Ltd.1998-05-20
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 (K981423)Autogenesis, Inc.1998-05-20
ELECTROSURGICAL CAUTERY PROBES (K981188)Microline Pentax, Inc.1998-05-20
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA (K981156)Smith & Nephew, Inc.1998-05-20
DUAL LOCK HIP STEM (K980794)Depuy, Inc.1998-05-20
20-HOLE ADAPTATION PLATE (K981070)Biomet, Inc.1998-05-20
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER (K980125)Norland Corp.1998-05-20
SKAR-KARE SHEET (K980563)Life Medical Sciences, Inc.1998-05-20
FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 (K981404)Fukuda Denshi USA, Inc.1998-05-20
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