Atlas FDA

1995

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

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RecordFirmDate
ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY (K944660)Neostar Medical Technologies, Inc.1995-03-13
CERVICAL FUNCTION INDICATOR (K943430)Whiplash Analysis, Inc.1995-03-13
ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS) (K950772)Argen Precious Metals, Inc.1995-03-13
OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL (K944943)Opti-Max1995-03-13
MYCOAKT M. AVIUM CULTURE ID KIT (K943049)Dynagen, Inc.1995-03-13
CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950186)Miles, Inc.1995-03-13
E-Z SET(R) AND MINICATH(R) INFUSION SETS (K950302)Becton Dickinson Vascular Access, Inc.1995-03-13
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS (K946204)Scimed Life Systems, Inc.1995-03-13
MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT (K943051)Dynagen, Inc.1995-03-13
MYCOAKT M KANSASII CULTURE ID KIT (K943050)Dynagen, Inc.1995-03-13
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) (K941427)Teco Diagnostics1995-03-13
ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR (K942344)Zoll Medical Corp1995-03-13
MS CLASSIQUE BALLOON CATHETER (K944143)Meadox Surgimed, Inc.1995-03-13
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED (K942458)Randox Laboratories, Ltd.1995-03-13
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION (K935544)Implant Innovations International, Inc.1995-03-13
FLUTTER(R) (K946083)Bradstreet Clinical Research Assoc., Inc.1995-03-13
PICCOLO(TM) (K942782)Abaxis, Inc.1995-03-13
COAT-A-COUNT NEONATAL TSH IRMA (K943195)Diagnostic Products Corp.1995-03-13
FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET (K945396)B.Braun Medical, Inc.1995-03-13
HY-TEC AUTOMATED EIA SYSTEM (K941278)Hycor Biomedical, Inc.1995-03-13
BEECH PRO LOK FIXED (K946082)Beech Medical Products, Inc.1995-03-13
GAMBRO FH 66 D HEMOFILTER (K933883)Cobe Renal Care, Inc.1995-03-13
COMPA LAB-R (K950765)Robert W. Bauer & Assoc., Inc.1995-03-13
SAFE-STEP (K931517)Lenjoy Engineering, Inc.1995-03-10
IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) (K944933)Diagnostic Products Corp.1995-03-10
PULSE HEART RATE MONITOR (K943243)Sensor Dynamics, Inc.1995-03-10
DISPOSABLE ADHESIVE FACE MASK (K950771)Advanced Warming Systems, Inc.1995-03-10
3002 AEROMAX (K942444)Medical Industries America, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM (K946288)Copan Diagnostics, Inc.1995-03-10
SPINALPLANE (K934336)Synvasive Technology, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM (K946286)Copan Diagnostics, Inc.1995-03-10
STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 (K942694)Biodex Medical Systems, Inc.1995-03-10
MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER (K950710)Microquartz Medical, Inc.1995-03-10
KRDL 2000 (K944819)Physicians Consulting, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM STUARTS MEDIUM (K946285)Copan Diagnostics, Inc.1995-03-10
CPR MICROSHIELD II (K950770)Plasco, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM (K946283)Copan Diagnostics, Inc.1995-03-10
ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM (K943882)Radiometer America, Inc.1995-03-10
CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE (K950661)Candela Laser Corp.1995-03-10
SUNDT SLIM-LINE GRAFT CLIPS (K912456)Codman & Shurtleff, Inc.1995-03-10
VARELISA DSDNA ANTIBODIES (FARR VERSION) (K950031)Elias U.S.A., Inc.1995-03-10
PRO-SPORT HEART RATE MONITOR (K943242)Sensor Dynamics, Inc.1995-03-10
DUPONT ACA VANCOMYCIN (VANC) METHOD (K945125)The DU Pont Co.1995-03-10
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (K946284)Copan Diagnostics, Inc.1995-03-10
DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT (K950662)Laserscope1995-03-10
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM (K933494)Exactech, Inc.1995-03-10
CPR MICROMASK PLUS CATALOG NO 73-402 (K950769)Plasco, Inc.1995-03-10
DELFIA NEONATAL THYROXINE KIT (K943416)Wallac OY1995-03-10
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (K946287)Copan Diagnostics, Inc.1995-03-10
SLASE 210 PLUS HOLMIUM LASER SYSTEM (K945156)New Star Lasers, Inc.1995-03-09
WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER (K941350)Wilson-Cook Medical, Inc.1995-03-09
FUJI MEDICAL LASER IMAGER FL-IM D (K945475)Fujifilm Medical System U.S.A., Inc.1995-03-09
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (K945523)Roche Diagnostic Systems, Inc.1995-03-09
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (K945280)Dupont Medical Products1995-03-09
ENTAMOEBA TEST (K944791)Techlab, Inc.1995-03-09
NOPROFILE OLBERT CATHETER SYSTEM (K945061)Meadox Surgimed, Inc.1995-03-09
CYPERFLO PERIPHERALLY INSERTED CATHETER (K935145)Cyex Medical Technologies, Inc.1995-03-09
STAT PROFILE PLUS 9 ANALYZER (K936066)Nova Biomedical Corp.1995-03-09
CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS (K943292)Candela Laser Corp.1995-03-09
VARIOUS TUBING (K943206)Prn Services, Inc.1995-03-09
SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION (K945428)Multi-Dimensional Imaging, Inc.1995-03-09
STAT PROFILE PLUS 10 ANALYZER (K936203)Nova Biomedical Corp.1995-03-09
REUSABLE MONOPOLAR FORCEPS (K950877)Boston Surgical Products, Inc.1995-03-09
TCD OR TCD NEUROPATHY STAR (K944234)Jcm Management & Planning Co.1995-03-08
ALTRES(R) 170 HEMODIALYZER (K945597)Althin Medical AB an Affiliate of Baxter Intl1995-03-08
NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER (K945947)Nellcor, Inc.1995-03-08
TRAV-LER KIT (K943942)John O. Butler Co.1995-03-08
BRANEMARK SYSTEM 3.3MM FIXTURE (K944683)Nobelpharma USA, Inc.1995-03-08
URO-FLO (K945140)Mallinckrodt Group, Inc.1995-03-08
FUJI ORTHO LC (K950556)GC America, Inc.1995-03-08
FRANCE ORTHODONTIE (K950121)France Orthodontie1995-03-08
LSVP INTERNATIONAL GRASPING FORCEPS (K945295)Lsvp Intl., Inc.1995-03-08
URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (K944972)Myo/Kinetic Systems, Inc.1995-03-08
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG (K946043)Rudolf Riester GmbH & Co. KG1995-03-08
ALTRES(R) 140 HEMODIALYZER (K945596)Althin Medical AB an Affiliate of Baxter Intl1995-03-08
ALTREX(R) 200 HEMODIALYZER (K945595)Althin Medical AB an Affiliate of Baxter Intl1995-03-08
SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED) (K943255)Wembley Rubber Products (M) Sdn Bhd1995-03-07
PERCUTANEOUS GRAINAGE CATHETER (K943893)Menlo Care, Inc.1995-03-07
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST (K933786)Immco Diagnostics, Inc.1995-03-07
DELTA THERM COLD THERAPY SYSTEM (K945399)Deltatherm1995-03-07
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB) (K934515)Zimmer, Inc.1995-03-07
IMD PSD 410 PACEMAKER TRANSMITTER (K943995)Integrated Medical Devices, Inc.1995-03-07
FLUOR PROTECTOR (K946032)Ivoclar North America, Inc.1995-03-07
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE (K945294)Howmedica Corp.1995-03-07
KAO YING (K946010)Kao Ying Industrial Co., Ltd.1995-03-07
SURGI-LINK BIPOLAR MICRO FORCEPS (K946246)Unimed Surgical Products, Inc.1995-03-07
KIRSCHNER (K-WIRE), STEINMAN PINS (K945670)Brasseler USA I, L.P.1995-03-07
MEDI PLUS SURGEON'S GLOVES (K945363)P.T. Saptindo Surgica1995-03-07
TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT (K950514)3M Unitek1995-03-07
KARMA WHEELCHAIR (K950195)Karman Healthcare, Inc.1995-03-07
NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR (K940739)Newport Medical Instruments, Inc.1995-03-07
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS (K945964)Sherwood Medical Co.1995-03-07
THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES (K950655)Ultrassage, Inc.1995-03-07
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST (K933788)Immco Diagnostics, Inc.1995-03-07
SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA (K945839)Sa Scientific, Inc.1995-03-07
RESOUND(R) RESOURCE(TM) (K945750)Resound Corp.1995-03-07
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K945235)Baxter Diagnostics, Inc.1995-03-07
BBLCRYSTAL ANAEROBE ID SYSTEM (K944528)Becton Dickinson Microbiology Systems1995-03-07
AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT (K950512)American Dental Products, Inc.1995-03-07
COMFIT BLUE POWDER FREE EXAMINATION GLOVES (K943563)Wembley Rubber Products (M) Sdn Bhd1995-03-07
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