Atlas FDA

1995

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

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RecordFirmDate
AXSYM OPIATES (K951287)Abbott Laboratories1995-05-18
COMFIT/BEADED SURGEON'S GLOVE (K951662)Wembley Rubber Products (M) Sdn Bhd1995-05-17
WELCH ALLYN HI - LUX ILLUMINATOR (K951647)Welch Allyn, Inc.1995-05-17
COMFIT (PINK) (K943601)Wembley Rubber Products (M) Sdn Bhd1995-05-17
PULSE*SPRAY INFUSION SYSTEM (K950907)Angiodynamics, Div. E-Z-Em, Inc.1995-05-17
ASH-7000 (K951228)U.S. Table, Inc.1995-05-17
OPTA 5(TM) 5F PTA BALLOON CATHETER (K950119)Cordis Corp.1995-05-17
SCIPOTEX/POWDER FREE EXAMINATION GLOVES (K951668)Wembley Rubber Products (M) Sdn Bhd1995-05-17
ALL POLYETHYLENE CEMENTED ACETABULAR CUP (K943696)Depuy, Inc.1995-05-17
ALPHA SYSTEM (K950312)Zimmer, Inc.1995-05-17
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE (K950487)Graphic Controls Corp.1995-05-17
PROFEEL (K951661)Wembley Rubber Products (M) Sdn Bhd1995-05-17
VANGUARD (K946084)Vanguard Container Corp.1995-05-17
BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR (K950663)Bei Medical Systems Co., Inc.1995-05-17
IMX ESTRADIOL (K951629)Abbott Laboratories1995-05-17
AIRGUIDE STYLETTE (K950713)Polamedco, Inc.1995-05-17
GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE (K950486)Graphic Controls Corp.1995-05-17
STONE DISLODGER, BASKET (K951309)Boston Scientific Corp1995-05-17
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (K951450)Strenumed, Inc.1995-05-17
ASSURE, SELF-SEALING STERILIZATION POUCH (K951590)Sultan Chemists, Inc.1995-05-17
MED-SURG SUTURE WASHER (K950250)Medical Surgical, Inc.1995-05-17
TELPHONIC STETHOSCOPE (K945638)American Telecare, Inc.1995-05-17
1700 MONITORING ECG ELECTRODE (K946273)Conmed Andover Medical, Inc.1995-05-17
PRECISION OSTEOLOCK FEMORAL COMPONENT (K944592)Howmedica Corp.1995-05-17
SPACELABS MEDICAL ECG MODULE (MODEL 90492) (K942058)Spacelabs Medical, Inc.1995-05-17
PICIS CHART+ (K950536)Picis1995-05-17
ECLIPSE 4 ELECTROCARDIOGRAPH (K943959)Burdick, Inc.1995-05-17
COMFIT/GREEN POWDERED EXAMINATION GLOVES (K951667)Wembley Rubber Products (M) Sdn Bhd1995-05-17
DI ISOLATION GOWN (K942351)Derekduck Industries Corp.1995-05-17
STERILE EQUIPMENT COVER (K951214)Gulfstream Medical1995-05-16
PFC CEMENT RESTRICTOR (K951934)Johnson & Johnson Professionals, Inc.1995-05-16
NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS (K951731)American Hydro-Surgical Instruments, Inc.1995-05-16
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 (K945651)Bio-Rad1995-05-16
HOWMEDICE BONE PLUG (K951860)Howmedica Corp.1995-05-16
ORTHO ALT MICROWELL TEST SYSTEM (K941192)Ortho Diagnostic Systems, Inc.1995-05-16
MPM HYDROGEL DRESSING (K950934)Richard Hamer Assoc., Inc.1995-05-16
EMS I.V. START KIT (K951167)Emergency Medical Supply, Inc.1995-05-16
AXSYM BENZODIAZEPINES (K951286)Abbott Laboratories1995-05-16
EXETER INTRAMEDULLARY BONE PLUG (K933077)Howmedica Corp.1995-05-16
ACE(TM) CEDIA(R) FERRITIN ASSAY (K950393)Schiapparelli Biosystems, Inc.1995-05-16
INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM (K944327)Calcitek, Inc.1995-05-16
TS1 TURTLE(TM) SYRINGE (K936225)Kershenstine Diamond, Inc.1995-05-16
AXSYM CANNABINOIDS (K951288)Abbott Laboratories1995-05-16
ABBOTT AXSYM II SYSTEM (K950915)Abbott Laboratories1995-05-16
DRYSLIDE COAGULASE (K950706)Difco Laboratories, Inc.1995-05-16
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT (K951625)KARL STORZ Endoscopy-America, Inc.1995-05-16
TRANSIT-2 INFUSION CATHETER (K950909)Cordis Neurovascular, Inc.1995-05-16
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES (K950455)Aaron Medical Industries1995-05-16
MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY (K950681)Invacare Corp.1995-05-16
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING (K944856)Wrightmedicaltechnologyinc1995-05-16
RYDER CONTACT LENS CASE MODEL 10670 (K951182)Bradstreet Clinical Research Assoc., Inc.1995-05-16
NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER (K951907)Navarre Biomedical , Ltd.1995-05-15
IMAGYN INTRAUTERINE INSEMINATION DEVICE (K945131)Imagyn Medical, Inc.1995-05-15
COAT-A-COUNT LH IRMA (K951748)Diagnostic Products Corp.1995-05-15
IL TEST BETA-2MICROGLOBULIN (K943686)Instrumentation Laboratory CO1995-05-15
SIRESKOP SX (K951358)Siemens Medical Solutions USA, Inc.1995-05-15
ADD POWER FAMILY , MICRO ADDSTAT (K945614)Laserscope1995-05-15
CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO (K950753)Stephen Chakoff, Inc.1995-05-15
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (K924306)United States Endoscopy Group, Inc.1995-05-15
HYDRACARE ABSORBENT WOUND DRESSING (K951914)Acacia Laboratories, Inc.1995-05-15
RINGLOC CONSTRAINED LINER (K950202)Biomet, Inc.1995-05-15
HICHEM ALT REAGENT KIT (K951818)Hi Chem, Inc.1995-05-15
KODAK X-OMAT 3000 RA PROCESSOR (K951396)Eastman Kodak Company1995-05-15
MARDX ENA EIA TEST SYSTEM (K946218)Hogan & Hartson1995-05-15
POLYSCAN DIGITAL SCANNER (K944684)Mse Medizintechnik GmbH & Co. KG1995-05-15
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES (K950751)Medtronic Vascular1995-05-15
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS (K950752)Advanced Cardiovascular Systems, Inc.1995-05-15
KODAK X-OMAT 5000 RA PROCESSOR (K951397)Eastman Kodak Company1995-05-15
KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE (K951826)KARL STORZ Endoscopy-America, Inc.1995-05-15
AVD INTIMAX THROMBECTOMY CATHETER (K950586)Applied Medical Resources1995-05-15
CROSS PIN SCREW SYSTEM (K946228)Depuy, Inc.1995-05-15
TRANSAMERICAN CLASSIC TENS (K944280)Transamerica Biomedical, Inc.1995-05-15
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (K943929)Greenleaf Medical Systems, Inc.1995-05-15
ARGUS ARTHROSCOPY INSTRUMENT SYSTEM (K950242)Argus Medical Co., Inc.1995-05-15
T-UPTAKE EIA TEST (K951586)Diagnostic Reagents, Inc.1995-05-15
BIOPSY DEVICE ACCESSORY (K951326)Biopsys Medical, Inc.1995-05-15
APOFIX CERVICAL SPINE FIXATION (K945022)Sofamor Co.1995-05-15
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL (K951635)Beckman Instruments, Inc.1995-05-15
NMI SOFTWARE (K950270)Nicolet Biomedical, Inc.1995-05-15
DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED (K950010)Johnson & Johnson Professionals, Inc.1995-05-15
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188)Cardiac Control Systems, Inc.1995-05-15
TRAX(TM) CD4 TEST KIT (K925255)T Cell Diagnostics, Inc.1995-05-15
IMAGERT (K942346)Impac Medical Systems, Inc.1995-05-15
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 (K950420)Analogic Corp.1995-05-15
RICH-MAR US-II ULTRASOUND (K950564)Rich-Mar Corp.1995-05-15
MARDX MITOCHONDRIA EIA TEST SYSTEM (K950110)Hogan & Hartson1995-05-15
NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (K950524)Nichols Institute1995-05-15
THE MODEL ACAPPELLA IN THE EAR HEARING AID (K943961)Telex Communications, Inc.1995-05-15
PADGETT AIR DERMATOME, MODEL A (K951085)Padgett Instruments, Inc.1995-05-15
TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (K950128)Emd Chemicals, Inc.1995-05-15
ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE (K926073)Surgimark, Inc.1995-05-15
AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL (K951427)American Dental Products, Inc.1995-05-15
ACE AMYLASE REAGENT (K951548)Schiapparelli Biosystems, Inc.1995-05-15
BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 (K951749)Biocell Laboratories, Inc.1995-05-15
PACS EQUIPMENT (K943994)Rstar Image Management System1995-05-12
MECHANICAL WHEERCHAIR- ECLIPSE (K945150)Colours 'N Motion1995-05-12
PERFECT, ENT SET, PRAKTIKANT, DE LUXE (K950913)Rudolf Riester GmbH & Co. KG1995-05-12
PERMAQUIK BONDING PRIMER (K951583)Ultradent Products, Inc.1995-05-12
COBE CENTRYSYSTEM CS500 DIALYZER (K941708)C.G.H. Medical, Inc.1995-05-12
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES (K945907)KARL STORZ Endoscopy-America, Inc.1995-05-12
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Every clearance here is in the API, with alerts when new ones post.