Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT (K940307)Howmedica, Inc.1995-01-19
ENDOCARE CRYOTHERAPY SYSTEM (K942299)Cytocare, Inc.1995-01-19
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD (K945090)Howmedica Corp.1995-01-19
HNR-PC HIP (K945094)Howmedica Corp.1995-01-19
NEONATAL RESTRAINT AND COMFORT SYSTEMS (K943017)K.Bowmed, Inc.1995-01-19
P.C.A. E-SERIES HIP- CEMENTLESS USE (K945093)Howmedica, Inc.1995-01-19
S.T.E.P. UNI-KNEE (K940389)S.T.E.P. Orthopaedics, Inc.1995-01-19
MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT (K945707)Minxray, Inc.1995-01-19
NASAL SPLINT (K945555)Ultracell Medical Technologies, Inc.1995-01-19
P.C.A.PRIMARY HIP- CEMENTLESS USE (K945092)Howmedica Corp.1995-01-19
ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT (K945202)Ethicon Endo-Surgery, Inc.1995-01-19
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION (K934917)Resound Corp.1995-01-19
SHOULDER RETRACTOR (K944613)Northwest Medical Physics Center1995-01-18
AGILANCE-GOLDEN SPOONS (K936178)Oismuller & Partner Keg1995-01-18
PREMIER MIRROR WARMER (K945395)Premier Dental Products Co.1995-01-18
SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM) (K944980)Hearing Solutions, Inc.1995-01-18
MEDI-PUMP (K944399)Thomas Industries1995-01-18
KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS (K946164)KARL STORZ Endoscopy-America, Inc.1995-01-18
IL TEST PHENOBARBITAL CALIBRATORS (K943981)Instrumentation Laboratory CO1995-01-18
VICRYL RAPIDE SUTURE (K944110)ETHICON, Inc.1995-01-18
HOWMEDICA ALUMINA FEMORAL HEAD (K945091)Howmedica Corp.1995-01-18
QUIK-STITCH (K945170)Coral Medical, Inc.1995-01-18
ECLIPSE 3200 (K945126)Cardiogenes1995-01-18
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM (K930836)Howmedica Corp.1995-01-18
TROCAR CANNULA STABILIZER (K950005)Advanced Surgical, Inc.1995-01-18
CTS RELIEF KIT (K941651)Linvatec Corp.1995-01-18
UROTEK LASER CATHETER (K945560)Energy Life Systems Corp.1995-01-18
ANTERIOR/POSTERIOR EPISTAXIS CATHETER (K945556)Ultracell Medical Technologies, Inc.1995-01-18
MOBILIX MOBILE X-RAY TABLE (K945842)GE Medical Systems1995-01-18
STERILE EXTRA PROTECION SURGEON'S GLOVES (K922979)Ansell Malaysia Sdn Bhd1995-01-18
EMG TRAINER (K935853)Unitech1995-01-18
VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE (K945952)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-01-18
KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM (K936274)Kirschner Medical Corp.1995-01-18
OPEN LAPAROSCOPY TROCAR CONE SYSTEM (K941222)Richard Wolf Medical Instruments Corp.1995-01-18
IL TEST THEOPHYLLINE (K943979)Instrumentation Laboratory CO1995-01-18
HEARTPRINT (K942862)Medata, Inc.1995-01-18
NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES (K945381)KARL STORZ Endoscopy-America, Inc.1995-01-18
STERISEAL OPHTHALMIC CANNULA (K943932)Pharma-Plast, Ltd.1995-01-18
KODAK EKTACCHEM 950IRC ANALYZER (K946090)Clinical Diagnostic Systems, Inc.1995-01-17
CEDIA DAU OPIATE ASSAY (K945343)Microgenics Corp.1995-01-17
HEMOCUE B-GLUCOSE SYSTEM (K943432)Hemocue, Inc.1995-01-17
EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS (K933610)Exactech, Inc.1995-01-17
SPECTRUM CO-OXIMETER LINEARITY CONTROL (K945860)Phoenix Diagnostics, Inc.1995-01-17
BIOMERIEUX HEMOLAB COFAC VII (K935850)Biomerieux Vitek, Inc.1995-01-17
THE KARL STORZ ARTHROPUMP (K942298)KARL STORZ Endoscopy-America, Inc.1995-01-17
GLUCOCHEK (K940215)Clinical Diagnostics, Inc.1995-01-17
SUNGLASSES (K946256)Chanel, Inc.1995-01-17
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT (K945378)Pulpdent Corp.1995-01-17
ELASTYREN(R) SURGICAL GLOVES (K945833)Eci Medical Technologies, Inc.1995-01-17
EYEWEAR/SPECTACLES (K945925)Kovision Mfg., Ltd.1995-01-17
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (K945172)Visitec Co.1995-01-17
BIOMERIEUX HEMOLAB COFAC X (K935851)Biomerieux Vitek, Inc.1995-01-17
PASCO MIC AND MIC/ID PANELS (K946126)Pasco Laboratories, Inc.1995-01-17
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (K945718)Casco Standards1995-01-17
QUEST CORONARY SINUS PERFUSION CANNULA (K941166)Quest Medical, Inc.1995-01-17
KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM (K942664)The Kendal Co.1995-01-17
MODEL 2721 CLINICAL REFRACTOMETER (K941901)Vee Gee Scientific, Inc.1995-01-17
RI-SCOPE S OTOSCOPE (K945640)Rudolf Riester GmbH & Co. KG1995-01-17
CEDIA(R) DAU PCP ASSAY (K946059)Microgenics Corp.1995-01-17
MODEL 2730 CLINICAL REFRACTOMETER (K941906)Vee Gee Scientific, Inc.1995-01-17
PROWAY (K946132)Union Industrial Co., Ltd.1995-01-17
QUANITITATE GBCC VERIFIER SET (K944454)Beckman Instruments, Inc.1995-01-17
CEDIA DAU COCAINE ASSAY (K945345)Microgenics Corp.1995-01-17
SAS QUANT HCG SERUM (K944785)Sa Scientific, Inc.1995-01-17
CEDIA(R) FOLATE (NO BOIL) ASSAY (K946184)Microgenics Corp.1995-01-17
AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT (K942661)Sealite Sciences, Inc.1995-01-17
EYE COOLER (K946231)Direct Import Marketing Co.1995-01-17
THEOPHYLLINE CALIBRATORS (K945338)Diagnostic Reagents, Inc.1995-01-17
QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) (K944455)Beckman Instruments, Inc.1995-01-17
EASY LYTE CALCIUM ANALYZER (K943091)Medica Corp.1995-01-17
LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) (K946155)Mala Intertrade Co., Ltd.1995-01-17
MODEL 2740 CLINICAL REFRACTOMETER (K941903)Vee Gee Scientific, Inc.1995-01-17
ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT (K941755)Wrightmedicaltechnologyinc1995-01-17
HCG MIDSTREAM PREGNANCY TEST (K945568)Mizuho USA, Inc.1995-01-17
SUNGLASSES (K945920)Glendale Protective Technologies, Inc.1995-01-17
VERSASAE PLASTIC CANNULA- 11 GAUGE (K945070)Imed Corp.1995-01-13
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE (K945513)Mallinckrodt Medical1995-01-13
SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER (K945593)Scimed Life Systems, Inc.1995-01-13
THE VANGUARD SYSTEM (K941551)Cleveland Clinic Foundation1995-01-13
ROAD WARRIOR (K935749)Redman, Inc.1995-01-13
HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR (K945040)Hamid M. Mehdizadeh, M.D.1995-01-13
SPIRO-FLEX (K945565)Inhalation Plastics1995-01-13
EXPIRATORY BREATHING EXERCISER (K945118)Dhd Diemolding Healthcare Div.1995-01-13
KOLBERG OPHTHALMIC CONFORMER (K945110)Kolberg Ocular Products, Inc.1995-01-13
BA-CPAS (K945154)Nobelpharma USA, Inc.1995-01-13
QUICK-LOCK (K945816)B&B Medical Technologies, Inc.1995-01-13
LATERAL FLEXION MACHINE (K940455)Rehab, Inc.1995-01-12
IRRIGATION TRAY (K944882)Clinical Resources, Inc.1995-01-12
PRO-TECT TRAUMA PAK (K941789)Pro-Tect Medical Products, Inc.1995-01-12
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD (K944601)Zimmer, Inc.1995-01-12
SPARTA HYDROGEL WOUND DRESSING (K945313)Sparta Surgical Corp.1995-01-12
BIOSTRIP STERILE WOUND CLOSURE STRIP (K946321)Cornelia Damsky, Inc.1995-01-12
HEINE LAMBDA 100 (K944156)Heine USA , Ltd.1995-01-12
SUNGLASSES (K945988)R.J. Standard Corp.1995-01-12
HAIR REMOVAL SYSTEM (K945192)L.P. Systems Corp.1995-01-12
APILUS ELECTROPIL (K943928)Dectro Intl., Inc.1995-01-12
LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS (K945960)Lorons International Corp.1995-01-12
ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS (K945545)Access Surgical Intl., Inc.1995-01-12
SPONGE COUNT (K945144)Michael Fischer Assoc.1995-01-12
CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS (K946269)Kendall Healthcare Products Co. Div.Of Tyco Health1995-01-12
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