Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
I-125 RAPID STRAND (K940632)Medi-Physics Inc. Dba Nycomed Amersham Imaging1994-09-02
ADVANCED THERAPY DOSIMETER (K942083)Keithley Instruments, Inc.1994-09-02
EXMOOR SINGLE USE MYRINGOTOMES (K942745)Exmoor Plastics , Ltd.1994-09-02
ARGESOL #760 (K943838)Argen Precious Metals, Inc.1994-09-02
MODEL 2600 PROCART (K941476)Compressor Technologies, Ltd.1994-09-02
GROMMENT STYLE VENTURI TUBE (K943849)Micromed Development Corp.1994-09-02
RANIR PLAX RX (K935906)Ranir/Dcp Corp.1994-09-02
SUNGLASSES (K941726)Yowmost Enterprise Co., Ltd.1994-09-02
TOTAL KNEE KIT (K932918)Biodynamic Technologies, Inc.1994-09-01
SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES (K941710)Scimed Peripheral Interventions1994-09-01
PRECISION OSTEOLOCK ACETABULAR COMPONENT (K930275)Howmedica Corp.1994-09-01
ORTHOLOC ADVANTIM (K933290)Wrightmedicaltechnologyinc1994-09-01
ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE (K934620)Wrightmedicaltechnologyinc1994-09-01
TECHMEDICA CONTINUUM HIP WITH HA COATING (K932017)Techmedica, Inc.1994-09-01
ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE (K943542)Conmedcorp1994-09-01
SLASE 210 PLUS HOLMIUM LASER SYSTEM (K942542)Sunrise Technologies, Inc.1994-09-01
PLTL-1 & PLDL-1 510NM PULSED DYE LASERS (K934811)Candela Laser Corp.1994-09-01
STAPLE, FIXATION BONE; SCREW FIXATION BONE (K931155)Roseburg SA1994-09-01
STRYKER 2S SPINAL SYSTEM (K930009)Stryker Corp.1994-09-01
O-R-EZ TIP CLEANER (K943991)O-R-Ez, Inc.1994-09-01
INDEX SPO2 SIMULATOR (K933519)Bio-Tek Instruments, Inc.1994-09-01
PROPAQ ECG TELEMETRY OPTION (K934711)Protocol Systems, Inc.1994-09-01
CLINICAL BLOOD GAS MIXTURE (K942866)Nordan Smith Welding Supplies1994-09-01
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 (K930843)National Medical Care, Medical Products Div., Inc.1994-08-31
JEMSDAL MASK (K942907)Respan Products, Inc.1994-08-31
SCIMED EN TRE' III PTCA GUIDE WIRE (K942333)Scimed Life Systems, Inc.1994-08-31
AG-839PA CO2 MODULE AND ACCESSORIES (K944027)Nihon Kohden America, Inc.1994-08-31
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM (K942939)Cordis Corp.1994-08-31
OPTICON(TM) CONNECTOR ADAPTER II (K942759)Xintec Corporation1994-08-31
SENTRY AQUEOUS GEL ECG ELECTRODES (K934000)Sentry Medical Products, Inc.1994-08-30
SEMEN ANALYSIS KIT (K915229)Humagen Fertility Diagnostics, Inc.1994-08-30
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES (K925560)Zinnanti Surgical Instruments, Inc.1994-08-30
LASER PHOTONICS ML755 DERMABLASER (K934501)Laser Photonics, Inc.1994-08-30
BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK (K940697)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-08-30
PIKOS E 01-B (K941937)Biotronik, Inc.1994-08-30
REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS (K936224)Mallinckrodt Medical Tpi, Inc.1994-08-30
ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (K941001)Diagnostic Specialties1994-08-30
CEDIA DAU BARBITURATE ASSAY (K942436)Microgenics Corp.1994-08-30
BACT/ALERT FAN AEROBIC CULTURE BOTTLE (K935711)Organon Teknika Corp.1994-08-30
DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS (K940908)Dunhall Pharmaceuticals, Inc.1994-08-29
OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (K925606)Chiron Vision Corp.1994-08-29
ARGESOL #720 (K943779)Argen Precious Metals, Inc.1994-08-29
MONOJECT TRAY SIZE SHARPS CONTAINER (K943496)Sherwood Medical Co.1994-08-29
STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY (K931731)Storz Instrument Co.1994-08-29
PESSARY FLEXIBLE SILICONE DONUT RING (K920747)Bioteque America, Inc.1994-08-29
SUNGLASSES (K943677)Jenn Wei Glass Company, Ltd.1994-08-29
IN-ROOM AND SHARPSTAR (K941991)Sage Products, Inc.1994-08-29
MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS (K943818)R-Med, Inc.1994-08-29
THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM (K930506)Pinecliff Assoc.1994-08-29
DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES (K923529)Seratronics, Inc.1994-08-29
O BUTMENT ES IMPLANT (K923889)O Co., Inc.1994-08-29
ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV (K942742)Wallace A. Erickson & Co.1994-08-29
SOFTWEAR PORCELAIN SYSTEM (K943582)Dentsply Intl.1994-08-29
LIFE-TELL T.S.S. (K932046)Raco Products Co.1994-08-29
SUNGLASSES (K943912)Kason Enterprises Limited1994-08-29
50 DEGREE HRI PRISM LENS (K941420)Ocular Instruments, Inc.1994-08-29
DR KOOL (K935841)Toronto Medical Corp.1994-08-29
NEW LUTING CEMENT MATERIAL (NLC) (K940914)Dentsply Intl.1994-08-29
MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR (K943191)Boston Scientific Corp1994-08-29
SONICATOR 730 (K943469)Mettler Electronics Corp.1994-08-29
SAVE-T-BREATH AMBILICAL CORD CLAMP (K933763)Save-T-Breath Distributors C.C.1994-08-29
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (K931763)Olympus Corp.1994-08-29
MDT UROLOGY TABLE (K942485)Mdt Corp., Inc.1994-08-26
HAND-HELD IRRIGATION PUMP (K933757)Ximed Medical Systems1994-08-26
ROCHE REAGENT FOR CREATININE (K941837)Roche Diagnostic Systems, Inc.1994-08-26
GAMBRO LUNDIA PRO 200 DIALYZER (K933680)Cobe Renal Care, Inc.1994-08-26
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE (K936271)Diagnostic Hybrids, Inc.1994-08-26
MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM (K943526)Ceram Optec, Inc.1994-08-26
STREP-A-CHEK(TM) REAGENT STRIPS (K940020)E-Y Laboratories, Inc.1994-08-26
APEX DISPOSABLE INSTRUMENTS (K941907)Apex Ent., Inc.1994-08-26
HYPERFLEX FLEXIBLE GUIDEWIRES (K941711)Linvatec Corp.1994-08-26
SLT PRISM/REFRACTING PROBE (K934208)Surgical Laser Technologies, Inc.1994-08-26
AURAFLEX SYSTEMS (K942443)Organon Teknika Corp.1994-08-26
ACCESS RED BLOOD CELL FOLATE ASSAY (K943149)Beckman Coulter, Inc.1994-08-26
MODULAR FORCEP AND SCISSOR SYSTEM (K935270)Richard Wolf Medical Instruments Corp.1994-08-26
AQUACISER II (K925193)Aquaciser, Inc.1994-08-26
STAR I WORKSTATION (K942290)Standard Engineering1994-08-26
LIVER BIOPSY KIT (K943650)Manan Medical Products, Inc.1994-08-26
EY-20 REAGENT TUBES (K940124)E-Y Laboratories, Inc.1994-08-26
MEGABEAM LATERAL FIRE (K943444)Ceram Optec, Inc.1994-08-26
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET (K942284)Creative Laboratory Products, Inc.1994-08-26
MEGABEAM FIBER OPTIC DELIVERY SYSTEM (K943445)Ceram Optec, Inc.1994-08-26
STREP-A-CHEK (K934129)E-Y Laboratories, Inc.1994-08-26
ARGON CURING LASER (K942204)Bio-Laser Technology, Inc.1994-08-26
EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) (K926218)Sandhill Scientific, Inc.1994-08-26
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE (K931029)Chalgren Enterprises, Inc.1994-08-25
PRESSURE INFUSION CUFF (K942933)Circulatory Technology, Inc.1994-08-25
SHARPLAN MODEL 1080S CO2 SURGICAL LASER (K933918)Sharplan Lasers, Inc.1994-08-25
EDGE (K941996)Philips Medical Systems (Cleveland), Inc.1994-08-25
SHARPSAFE CAT NO. 4105, 4115 AND 4120 (K942937)Smiths Industries Medical Systems, Inc.1994-08-25
DEEP SUTURE (K942818)Automated Medical Products Corp.1994-08-25
WINRAD TELERADIOLOGY SYSTEM (K936179)Line Imaging Systems1994-08-25
VIDEOTOSCOPE (K943916)Welch Allyn, Inc.1994-08-25
ARGYLE NEO-SERT (K942564)Sherwood Medical Co.1994-08-25
MEDIAID UNIVERSAL THERMOMETER (K941673)Polymedica Industries, Inc.1994-08-25
STRYKER 8000 SURGERY STRETCHER (K943864)Stryker Medical1994-08-25
CCD ENDOCAM OFFICE 5510 (K942817)Richard Wolf Medical Instruments Corp.1994-08-25
ARTHREX CIRCULAR HARVESTING SAW (K941681)Arthrex, Inc.1994-08-25
THICK TIBIAL INSERT (K933289)Wrightmedicaltechnologyinc1994-08-25
RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (K941781)Dacomed Corp.1994-08-25
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Every clearance here is in the API, with alerts when new ones post.