Atlas FDA

1995

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

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RecordFirmDate
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (K953582)Varian Canada, Inc.1995-09-26
HOWMEDICA MAINSTAY ANCHOR (K953531)Howmedica Corp.1995-09-26
SILK*SKIN SCAR TREATMENT (K953420)Silk*Skin Care Co.1995-09-26
TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA (K952674)Elscint, Inc.1995-09-26
AUKULYTE (K953610)Aukland Medical Plastics, Inc.1995-09-26
SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER (K952885)Spacelabs Medical, Inc.1995-09-26
VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS (K953804)Vistakon, Johnson & Johnson Vision Products, Inc.1995-09-26
AXSYM PHENYTOIN II (K953840)Abbott Laboratories1995-09-25
AXSYM DIGOXIN II (K953718)Abbott Laboratories1995-09-25
MEDRAD SPECTRIS MR INJECTOR (K935668)Medrad, Inc.1995-09-25
SPECTROLYSE ANTIPLASMIN KIT (K941752)Biopool AB1995-09-25
FASGUIDE (K951159)Target Therapeutics1995-09-25
MEDI-AID BASAL THERMOMETER (K952756)Polymedica Industries, Inc.1995-09-25
MECTEST (K945207)Meco Industries1995-09-25
ACTI-FLEX ARTERIAL EXTENSION SET (K954035)R-Group Intl.1995-09-25
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE (K950143)Astral, Ltd.1995-09-25
DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K (K952176)Medicotest, Inc.1995-09-25
BARRIER GOWN, KOOL-GARD BACKLESS GOWN (K952115)American Threshold Industries, Inc.1995-09-25
EBV-VCA IGM ELISA TEST STSTEM (K944449)Zeus Scientific, Inc.1995-09-25
KOOL GARD SINGLES GOWN (K952114)American Threshold Industries, Inc.1995-09-25
TWIN SILICONE CATHETER (K923691)Medical Components, Inc.1995-09-25
HEMA-TROL Q-CHECK (K952385)Medical Specialties Intl., Inc.1995-09-25
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE (K946005)Astral, Ltd.1995-09-25
QBC ACCUTUBE (K945205)Becton Dickinson Diagnostic Instrument Systems1995-09-25
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER (K953239)Boehringer Mannheim Corp.1995-09-25
PERSHIELD CPR DEVICE (K940820)Rabintex Industries, Ltd.1995-09-25
ACCESS ULTRASENSITIVE INSULIN ASSAY (K953084)Bio-Rad Laboratories, Inc.1995-09-25
ABBOTT AXSYM PROLACTIN(MODIFICATION) (K953657)Abbott Mfg., Inc.1995-09-25
OXY/STAR LOW FLOW BLENDER (K952878)Infrasonics Corp.1995-09-25
TECNOL ISLAND WOUND DRESSING (K954033)Tecnol Medical Products, Inc.1995-09-22
WELCH ALLYN VIDEO EPISCOPE (K952835)Welch Allyn, Inc.1995-09-22
MAXX (K946376)Mayer Laboratories1995-09-22
WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA (K953086)Woodbine Optical Corp.1995-09-22
MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE (K953138)Pwa Industries Sdn. Bhd.1995-09-22
QUICK READ 2000 (QR2000) (K953163)Quicksilver Systems, Inc.1995-09-22
MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM (K950276)Endosonics Corp.1995-09-22
BASIS DIGITAL THERMOMETER (K952159)Polymedica Industries, Inc.1995-09-22
ORS-111 (K953654)O.R. Solutions, Inc.1995-09-22
OLYMPIC PASTEURMATIC SYSTEM (K953645)Olympic Medical Corp.1995-09-22
PERI-PUSHER (K953046)Diacor, Inc.1995-09-22
PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING (K953669)Marketing Perspectives1995-09-22
MULTI-PRIME AKA/MONO-PRIME (K953476)Silicon-Und Composite Spezialitaten GmbH1995-09-22
ILIAC CREST BONE MARROW ASPIRATION NEEDLE (K953082)Baxter Healthcare Corp1995-09-22
TELESCOPING PENEVAC (K954088)I.C Medical, Inc.1995-09-22
EGNELL ELITE (K950531)Hollister, Inc.1995-09-22
KIMONO (CONDOMS) (K943064)Mayer Laboratories1995-09-22
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT (K954231)Promex, Inc.1995-09-22
COLLAPSIBLE HYPODERMIC SYRINGE (K951980)Roman Vladimirsky1995-09-22
THE TULIP J DISSECTOR (K952965)The Tulip Mfg. Co.1995-09-22
PHOENIX 3.25 MM HA COATED DENTAL IMPLANT (K926367)International Implant Seminars1995-09-21
PRECEDER GUIDEWIRE (K953023)Boston Scientific Corp1995-09-21
BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) (K953775)Nobelpharma USA, Inc.1995-09-21
STA-COAG CONTROL [P] PLUS KIT (K952338)American Bioproducts Co.1995-09-21
PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS (K926311)Vancouver Implant Center1995-09-21
WELLS JOHNSON FIXATION SYSTEM (K945500)Wells Johnson Co.1995-09-21
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE (K952058)Trinity Laboratories, Inc.1995-09-21
INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) (K952160)Medex, Inc.1995-09-21
POLY-LITE MODEL 1000 (K954061)Pro-Den Systems, Inc.1995-09-21
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (K950803)Isolab, Inc.1995-09-21
PHOENIX 4.0 MM DENTAL IMPLANT (K926309)Vancouver Implant Center1995-09-21
ABUTMENT (K953836)Steri-Oss, Inc.1995-09-21
STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS (K926370)International Implant Seminars1995-09-21
JT-3 ELECTROGNATHOGRAPH (K952218)Bio-Research Associates, Inc.1995-09-21
INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM (K943180)Calcitek, Inc.1995-09-21
XLS-300 XENON LIGHT SOURCE (K953924)Specialties of Surgery1995-09-21
CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE (K952427)Beckman Instruments, Inc.1995-09-21
OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS (K952592)Opti-Max1995-09-21
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) (K950331)Healthdyne, Inc.1995-09-21
PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT (K926366)International Implant Seminars1995-09-21
OXILINK (SMALL, MEDIUM, LARGE) (K953126)Bci Intl., Inc.1995-09-21
VACUTAINER PLUS TUBES (K953463)Becton Dickinson Vacutainer Systems1995-09-20
RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR (K941252)Ansar1995-09-20
IRON/TIBC REAGENT (K935712)Horizon Diagnostics, Inc.1995-09-20
RELAXPLUS (K951213)Ultramind International , Ltd.1995-09-20
ABUSCREEN ONLINE CONTROLS (K953739)Roche Diagnostic Systems, Inc.1995-09-20
ABUSCREEN ONLINE DRUG FREE URINE (K953845)Roche Diagnostic Systems, Inc.1995-09-20
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR (K952862)Fujifilm Medical System U.S.A., Inc.1995-09-20
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II (K952720)Aalto Scientific, Ltd.1995-09-20
ROCHE CALIBRATOR SERUM (K942706)Roche Diagnostic Systems, Inc.1995-09-20
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR (K953951)Wilson-Cook Medical, Inc.1995-09-19
BUCHALTER FAUSER FEMORAL COMPONENTS (K952686)Biomet, Inc.1995-09-19
CROSSVENT-4 VENTILATOR (K942938)Bio-Med Devices, Inc.1995-09-19
MARSAM MODEL 2000 NEBULIZER (K933961)Marsam Pharmaceuticals, Inc.1995-09-19
LIFEMASK FACE SHIELD (K953824)Carefree Trading, Inc.1995-09-19
LOW PROFILE TITANIUM MODEL CATALOG #1003 (K953073)Arrow Intl., Inc.1995-09-19
SLEEP TEST(TM) (K950273)Cns, Inc.1995-09-19
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (K953786)Unicor, Inc.1995-09-19
ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES (K952068)Zimmer, Inc.1995-09-19
DANTEC KEYPOINT (K944547)Mckenna & Cuneo1995-09-19
ADI SYSTEM (K933825)Abbott Laboratories1995-09-19
LAPAROSCOPIC SURGICAL INSTRUMENT (K953548)Gabris Surgical Corp.1995-09-19
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (K953788)Unicor, Inc.1995-09-19
EBNA IGG ELISA TEST (K935730)Gull Laboratories, Inc.1995-09-19
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (K953787)Unicor, Inc.1995-09-19
AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (K940320)Ad-Tech Medical Instrument Corp1995-09-19
STOMAVISION (STV) (K951074)Trophy Radiologie1995-09-19
STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS (K951666)Stryker Instruments1995-09-19
SCIMED TRIGUIDE GUIDE CATHETERS (K953515)Scimed Life Systems, Inc.1995-09-19
DISPOSABLE, CPAP OXYGEN MASK (K945482)Fvtnks1995-09-19
LIFE SOUND SENSOR (K952651)Flowscan, Inc.1995-09-19
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Track 1995 automatically

Every clearance here is in the API, with alerts when new ones post.