Atlas FDA

1995

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

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RecordFirmDate
ELITE BIOFEEDBACK (K942563)Laborie Medical Technologies, Ltd.1995-06-06
PRIMALLOR 1 (K951784)Degussa Corp.1995-06-06
FAIRY WORLD INC (K951992)Fairy World, Inc.1995-06-06
WELCH ALLYN VIDEO OPHTHALMOSCOPE (K951210)Welch Allyn, Inc.1995-06-06
VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM (K946177)Valleylab, Inc.1995-06-06
NEPHRO-URETERAL STENT (K942688)Uresil Corp.1995-06-06
STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS (K945956)Strato Medical Corp.1995-06-06
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 (K944999)More Diagnostics1995-06-06
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING (K945379)Boston Scientific Corp1995-06-05
DECA DERMATOME (MICROMOTOR SYSTEM) (K945594)Depuy Intl., Ltd.1995-06-05
NATURE'S CRADLE (K951024)Infant Advantage, Inc.1995-06-05
VALLEYLAB FORCE FX (K944602)Valleylab, Inc.1995-06-05
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT (K952466)Olympus America, Inc.1995-06-05
HEARTRAC ECG MONITORING SYSTEM (K934913)Cardiac Telecom Corp.1995-06-05
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) (K952077)Hemagen Diagnostics, Inc.1995-06-05
KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE (K951804)KARL STORZ Endoscopy-America, Inc.1995-06-05
BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) (K951937)Bio Path1995-06-05
HEMAGEN ENA SCREENING KIT (EIA METHOD) (K952076)Hemagen Diagnostics, Inc.1995-06-05
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT (K952263)Siemens Hearing Instruments, Inc.1995-06-05
QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 (K952060)Image Analysis, Inc.1995-06-05
THIN-FILM CARDIAC GATING CABLE (K946085)General Electric Co.1995-06-05
COMPACT 7600 (K950781)Ge Dec Medical Systems1995-06-05
BRAINLAB MASK SYSTEM (K945903)Brainlab Med. Computersysteme GmbH1995-06-05
DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE (K951352)Davis & Geck, Inc.1995-06-05
NH-2002 (K932050)New Horizon Health Care1995-06-05
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE (K952228)Resound Corp.1995-06-05
DPD DEFIBRILLATOR (K952085)Medical Research Laboratories, Inc.1995-06-05
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION (K946332)KARL STORZ Endoscopy-America, Inc.1995-06-05
PROTECTIVE SHORTS (K943948)Y. Daneshvar, M.D.1995-06-05
POWDER FREE LATEX EXAMINATION GLOVES (K950450)Rampart Glove Co.1995-06-02
BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH (K950993)John O. Butler1995-06-02
HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER (K951098)Hdc Corp.1995-06-02
PIDURAL STEROID SYSTEM (K945484)Professional Medical Device Consultants1995-06-02
BOND-ON 4 (K951783)Degussa Corp.1995-06-02
MODEL 3200 VASCULAR MINI-LAB (K944495)Parks Medical Electronics, Inc.1995-06-02
W&H 898 TOP LIGHT HIGHSPEED (K944710)A-Dec, Inc.1995-06-02
RIONET HEARING AID HM-02 (K951677)Authorized Hearing Systems, Inc.1995-06-02
DEGULOR M (K951779)Degussa Corp.1995-06-02
W&H 798 TOP AIR TURBINE TRIPLE SPRAY (K944717)A-Dec, Inc.1995-06-02
NAVIGUIDE HYDROPHILIC GUIDE WIRE (K943358)Meadox Medicals, Div. Boston Scientific Corp.1995-06-02
NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER (K945909)Navarre Biomedical , Ltd.1995-06-02
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM (K951292)Chiron Vision Corp.1995-06-02
IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS (K950340)Bemis Mfg. Co.1995-06-02
BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA (K951047)Vital Signs, Inc.1995-06-02
NEUROSIGN 100 IMPEDANCE METER (K945799)The Magstim Company , Ltd.1995-06-02
MANDIBULAR BONE DISTRACTOR (K945674)Howmedica Corp.1995-06-02
MODEL 511 INFANT MONITOR (K942170)Ge Medical Systems Information Technologies1995-06-02
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE (K950956)Bio-Vascular, Inc.1995-06-02
MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM (K950957)Gulf Coast Hyperbarics, Inc.1995-06-02
AORTIC ARCH CANNULAS (K943934)Sorin Group Italia S.R.L.1995-06-02
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM (K950114)Storz Instrument Co.1995-06-02
STRATO/INFUSAID TUNNELER (K950987)Strato/Infusaid, Inc.1995-06-02
PORS ON PLUS (K951781)Degussa Corp.1995-06-02
DAVOL ARTHRO-FLO 3 (K951026)Davol Inc., Sub. C. R. Bard, Inc.1995-06-02
7050 ULTRASOUND IMAGING SYSTEM (K944287)Biosound, Inc.1995-06-02
W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY (K944708)A-Dec, Inc.1995-06-02
LIFEFORCE CLINICAL HYPERBARIC FACILITY (K951125)Reimers Systems, Inc.1995-06-02
MEGA MEDITEX LIMITED (K950622)Mega Meditex , Ltd.1995-06-02
THE SIGNATURE SERIES, M IV (K933197)Progressive Electrical Therapeutics1995-06-02
W&H 795 TOP AIR TURBINE SINGLE SPRAY (K944715)A-Dec, Inc.1995-06-02
PENTAX FACE MASK (K933683)Pentax Precision Instrument Corp.1995-06-02
STERILE TREATMENT ELECTRODE (K941923)Staodyne, Inc.1995-06-02
OSTEOTOMES (K952193)Steri-Oss, Inc.1995-06-02
W&H 796 TOP AIR TURBINE MINI-HEAD (K944716)A-Dec, Inc.1995-06-02
DYNABITE UROLOGICAL FORCEPS (K952391)Portlyn Corp.1995-06-01
MODEL 550-DC CROSSFIRE(TM) (K945564)Eclipse, Inc.1995-06-01
ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM (K950727)Lifescan, Inc.1995-06-01
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM (K950802)International Enzymes, Inc.1995-06-01
STABILOR NF IV (K951780)Degussa Corp.1995-06-01
HLT 406 (K951382)Health Care Mfg., Inc.1995-06-01
TEMPRA HEAT PACK (K951383)Tempra Technology, Inc.1995-06-01
IMMUNOASSAY DRUGS OF ABUSE CONTROLS (K952056)Medi-Tech, Inc.1995-06-01
STAPHAUREX PLUS(TM) (K945538)Murex Diagnostics Limitd1995-06-01
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION (K951319)Roche Diagnostic Systems, Inc.1995-06-01
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (K951966)Kent Laboratories, Inc.1995-06-01
ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES (K950592)Eare Consulting Service1995-06-01
GORE SMOOTHER GUIDED RASP (K951163)W. L. Gore & Associates, Inc.1995-06-01
STABILOR G (K951782)Degussa Corp.1995-06-01
HEP-2000 COLORZYME ANA-RO TEST SYSTEM (K950979)Immuno Concepts, Inc.1995-06-01
LASER GAS MIXTURE (K952301)Airgas Management, Inc.1995-06-01
SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR (K951204)Sharplan Lasers, Inc.1995-06-01
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION (K951058)Heraeus Kulzer, Inc.1995-06-01
DUPONT ACA DIGOXIN (DGN A) METHOD (K951441)E.I. Dupont DE Nemours & Co., Inc.1995-06-01
MEDICAL MIXTURE-LASER GAS MIXTURES (K952162)Standard Welders Supply Co.1995-06-01
EMIT 2000 DIGOXIN ASSAY (K951755)Syva Co.1995-06-01
TBN-TIPPED OPTICAL FIBER (K952113)Myriad Lase, Inc.1995-06-01
OSTEOGEN (HA RESORB) (K923310)Impladent1995-05-31
CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE (K945589)U.S. Medical Products, Inc.1995-05-31
HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER (K932388)Heart Rhythm Technologies, Inc.1995-05-31
PULPDENT GLASS IONOMER CEMENTS (K951270)Pulpdent Corp.1995-05-31
DEGUSTAR GA-2 (K951777)Degussa Corp.1995-05-31
CARDON PHSICAL THERAPY TABLE MODEL R27630 (K951953)Cardon Rehabilitation Products, Inc.1995-05-31
NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS (K951733)American Hydro-Surgical Instruments, Inc.1995-05-31
CARDON PHYSICAL THERAPY TABLE MODEL R27108 (K951954)Cardon Rehabilitation Products, Inc.1995-05-31
ACCU-BEAM FIBER OPTIC HANDPIECE (K952006)Tti Medical1995-05-31
E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS (K952053)Becton Dickinson Vascular Access, Inc.1995-05-31
S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS (K951084)Joint Medical Products Corp.1995-05-31
SUNLITE 1275 (K951465)Fen Dental Mfg., Inc.1995-05-31
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK (K951811)Osteotech, Inc.1995-05-31
BRYAN POSTERIOR SPINAL FIXATOR (BPSF) (K945435)Arcan Orthopaedic Corp.1995-05-31
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Every clearance here is in the API, with alerts when new ones post.