Atlas FDA

1995

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

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RecordFirmDate
MICRO ICS SONIC SCALER (K942380)Micro Motors, Inc.1995-08-07
PROTOUCH OVERGLOVE (K952241)Cottrell, Ltd.1995-08-07
STORZ DP4101 BASIC I/A PACK (K953078)Storz Instrument Co.1995-08-07
GOUVERNEUR AUDIGIER (K952758)Ets Gouverneur-Audigier1995-08-07
PHOTODERM VL. (K950493)Esc, Energy Systems Corp.1995-08-07
CRADLE FIXATION DEVICE (K941772)Neoligaments, Ltd.1995-08-07
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (K942200)Thantex Specialties, Inc.1995-08-07
COATEST(R) APC(TM) RESISTANCE (K945940)Axis-Shield Doc AS1995-08-07
BIOACCESS MARROW HARVEST SYSTEM (K953064)Bioaccess, Inc.1995-08-07
KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE (K952369)Physicians Consulting, Inc.1995-08-07
SOLUTION ADMINISTRATION SET (K952664)Distronic Sterile Products, Inc.1995-08-07
ZEROID HEMORRHOIDAL DEVICE (K944874)Medical Appliance Research Corp.1995-08-07
BALANCE MANAGER (K946229)Neurocom International, Inc.1995-08-04
VITALOGRAPH MODEL 2120 (K946075)Vitalograph, Inc.1995-08-04
AI-PHOTODIAGNOSTIC (K940004)Pharmarceutical Discovery Corp.1995-08-04
RUBELLA IGG ELISA TEST (K941624)Gull Laboratories, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM (K953320)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM (K953319)Sa Scientific, Inc.1995-08-04
V. MUELLER OBSTETRICAL (OB) FORCEPS (K951529)Baxter Healthcare Corp1995-08-04
SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM (K953316)Sa Scientific, Inc.1995-08-04
URINARY DRAINAGE BAG (K951597)Key Medical Services, Inc.1995-08-04
IL TEST CK-MB (K952646)Instrumentation Laboratory CO1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM (K953318)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM (K953317)Sa Scientific, Inc.1995-08-04
ELECTRONIC LAPAROFLATOR (K951694)KARL STORZ Endoscopy-America, Inc.1995-08-04
TOCO TRANSDUCER (K952579)Scientific Device Manufacturer, LLC1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM (K953321)Sa Scientific, Inc.1995-08-04
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS (K945826)Medical Device Inspection Co., Inc.1995-08-04
ACS POWERBASE GUILDING CATHETER (K952205)Advanced Cardiovascular Systems, Inc.1995-08-04
IMAGYN UROSCOPE (K953201)Imagyn Medical, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 2 ANTISERUM (K953323)Sa Scientific, Inc.1995-08-02
MAGNETIC HDL CHOLESTEROL TEST (K944975)Reference Diagnostics, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 6 ANTISERUM (K953327)Sa Scientific, Inc.1995-08-02
CEMAX VIPSTATION AND/OR SOFTWARE (K945188)Cemax, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 5 ANTISERUM (K953326)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 7 ANTISERUM (K953328)Sa Scientific, Inc.1995-08-02
ACS GENTAMICIN (K953020)Ciba Corning Diagnostics Corp.1995-08-02
5STRATEC SL 300 LIA-MAT (K950029)Nichols Institute Diagnostics1995-08-02
RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (K951366)Riken Keiki Co., Ltd.1995-08-02
HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS (K943654)Mdt Biologic Co.1995-08-02
ATRAUMATIC PENCIL POINT SPINAL NEEDLE (K945965)Avid N.I.T., Inc.1995-08-02
AXSYM COCAINE METABOLITE (K951289)Abbott Laboratories1995-08-02
RAPID-TRAK(TM) INTRODUCER SHEATH (K950155)Cardio Vascular Concepts, Inc.1995-08-02
ABSORBALBE ANCHOR (K944051)Mitek Surgical Products, Inc.1995-08-02
PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR (K946080)Portable Power Systems, Inc.1995-08-02
MCI OPTONIX ECONOMY CASSETTE (K953444)Mci Optonix, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 1 ANTISERUM (K953322)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII GROUP C2 ANTISERUM (K953329)Sa Scientific, Inc.1995-08-02
INJECTION NEEDLE (K953338)Boston Scientific Corp1995-08-02
RELAXU-1 (K950411)Kinsei Shiatsu, Inc.1995-08-02
HICHEM AST REAGENT KIT (K951751)Hichem Diagnostics1995-08-02
SAS SHIGELLA BOYDII TYPE 4 ANTISERUM (K953325)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 3 ANTISERUN (K953324)Sa Scientific, Inc.1995-08-02
CORDIS BRITE TIP, ENVOY GUIDING CATHETER (K952185)Cordis Corp.1995-08-02
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) (K953207)The Binding Site, Ltd.1995-08-01
IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENT (K951611)Imz, GmbH1995-08-01
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR (K951961)KARL STORZ Endoscopy-America, Inc.1995-08-01
ZEUA MYCOPLASMA (K944417)Zeus Scientific, Inc.1995-08-01
VIDEO SIGMOIDOSCOPE (K950429)Welch Allyn, Inc.1995-08-01
IMZ - DENTAL IMPLANT SURGICAL TRAY (K951609)Imz, GmbH1995-08-01
BIO-RAD URINARY 5-HIAA BY HPLC (K952817)Bio-Rad1995-08-01
IMX TOXO IGG (K951636)Abbott Laboratories1995-08-01
GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) (K950864)Acu Med, Inc.1995-07-31
IV POLE/STAND (K952196)Valentine Intl. , Ltd.1995-07-31
SLOAN STA-DRI BOOTLEG LEGGING (K944276)Sloan Corp.1995-07-31
ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER (K952757)Becton Dickinson Vascular Access, Inc.1995-07-31
MASTERSCREEN PFT BODY (K951901)Erich Jaeger GmbH & Co. KG1995-07-31
SLOAN STA-DRI SURGICAL JUMPSUIT (K944118)Sloan Corp.1995-07-31
HURRICANE (K952258)Hurricane Hardware, Inc.1995-07-31
PICC LINE KIT (K952256)Medi-Flex Hospital Products, Inc.1995-07-31
ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES (K945948)Ampri Rubberware Industries Sdn Bhd1995-07-31
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) (K953197)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-31
CATHETER, INTRAVASCULAR OR PERCUTANEOUS (K951078)Sims Deltec, Inc.1995-07-31
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS (K952555)Roche Diagnostic Systems, Inc.1995-07-31
WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT (K952691)Welch Allyn, Inc.1995-07-31
OTOSILK (K952203)Boston Medical Products, Inc.1995-07-31
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR (K953212)Randox Laboratories, Ltd.1995-07-31
BIOABSORBABLE INTERFERENCE SCREW (K943249)Instrument Makar, Inc.1995-07-31
TI. ALLOY 2.0 MM CORTEX SCREW (K952272)Synthes (Usa)1995-07-31
CANNULATED PLUS HIP SCREW (K952640)Wrightmedicaltechnologyinc1995-07-31
CHAMPION, 3000 REBEL (K953427)Kuschall of America1995-07-31
CHAMPION, 3000 (K953428)Kuschall of America1995-07-31
COMPETITOR (K953426)Kuschall of America1995-07-31
REDI DRILL DRILL SYSTEM (K952609)Trebay Medical Corp.1995-07-31
SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM (K951268)Spine-Tech, Inc.1995-07-31
SACS, INDEPENDENT FIBER COOLANT SYSTEM (K952754)Surgical Laser Technologies, Inc.1995-07-31
ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE (K952842)Ethicon Endo-Surgery, Inc.1995-07-31
ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) (K952325)Icor AB1995-07-31
CHAMPION, 1000 (K953429)Kuschall of America1995-07-31
COMFEEL PLUS PRESSURE RELIEF DRESSING (K951325)Richard Hamer Assoc., Inc.1995-07-31
VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM (K951077)Med Institute, Inc.1995-07-31
ANGIOCATH & INSYTE AUTOGUARD CATHETERS (K952861)Becton Dickinson Vascular Access, Inc.1995-07-31
AEROS ASPIRATOR (K952103)Aeros Instruments, Inc.1995-07-31
QUESTUS DISPOSABLE ENDOSCOPIC KNIFE (K952926)Wrightmedicaltechnologyinc1995-07-31
TOTAL CONTACT SEAT RIPPLE SYSTEM (K943433)Numotech, Inc.1995-07-31
MEDLITE LASER SYSTEM (K952636)Continuum Biomedical, Inc.1995-07-31
SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS (K952733)Myriad Lase, Inc.1995-07-31
BARRIER ALL FILM (K952234)Cottrell, Ltd.1995-07-31
CODMAN-MEDOS VALVE SHUNT SYSTEM (K944222)Johnson & Johnson Professionals, Inc.1995-07-28
ESSENTIAL SHAVER SYSTEM (K953096)Smith & Nephew Richards, Inc.1995-07-28
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