Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BALLET STERILE DISPOSABLE ELECTROLYSIS (K883892)Synoptic Products1988-10-20
CODMAN NEUROLASE LASER SYSTEM (K883642)I.L. Med, Inc.1988-10-20
JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS (K882234)Johnson & Johnson Professionals, Inc.1988-10-20
EXTRAVAKIT FOR RADIOLOGICAL APPLICATIONS (K883220)Cancer Technologies, Inc.1988-10-20
BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN (K883799)Austenal Dental, Inc.1988-10-20
SAMUELSON SCREWLOC CUP (K882671)Protek, Inc.1988-10-20
TANGENT II (K883974)Fischer Imaging Corp.1988-10-20
TDX AMPHETAMINE/METHAMPHETAMINE II (K883707)Abbott Laboratories1988-10-20
KISS OF MINT(TM) NON-LUBRICATED CONDOM (K882389)Ansell, Inc.1988-10-20
PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 (K882358)U.S. Imaging, Inc.1988-10-19
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A (K884040)Orion Diagnostica, Inc.1988-10-19
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (K884075)Orion Diagnostica, Inc.1988-10-19
DATEX AIRWAY MONITOR (K882885)Datex Division Instrumentarium Corp.1988-10-19
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000) (K883519)Philips Medical Systems (Cleveland), Inc.1988-10-19
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR (K884101)E.I. Dupont DE Nemours & Co., Inc.1988-10-19
QM300 APOLIPOPROTEIN B ANTIBODY PACK (K883714)Kallestad Diag, A Div. of Erbamont, Inc.1988-10-19
KONTRON PULSE OXIMETER 7840 (K873624)Kontron Instruments, Inc.1988-10-19
STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS (K882532)Five Stars Alloys , Ltd.1988-10-19
RADKOR, RF-159 (K883885)Radkor, Inc.1988-10-19
CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS (K873772)Cordis Leads, Inc.1988-10-19
WILSON BIOMEDICAL CORONARY GUIDING CATHETER (K881793)Wilson Biomedical, Inc.1988-10-19
SCISSORS, WIRE CUTTING (K884095)Magnatrade Corp.1988-10-19
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM (K881305)Toshiba Medical Systems1988-10-19
OHMEDA CONTINUOUS SUCTION REGULATOR (K883229)Ohmeda Medical1988-10-19
NORMOCAP 200 CAPNOMETER (K882748)Datex Division Instrumentarium Corp.1988-10-19
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK (K883713)Kallestad Diag, A Div. of Erbamont, Inc.1988-10-19
RADKOR SFR-70 (K883864)Radkor, Inc.1988-10-19
FLOSER PLUS (K884145)Pacific Lin Intl., Co.1988-10-19
VISTA MR 2055 HP SYSTEM (K883482)Philips Medical Systems (Cleveland), Inc.1988-10-19
VISIO-PERL (K882566)Espe GmbH (Us)1988-10-19
NICOLET BRAINLAB SYSTEM (K882599)Nicolet Instrument Corp.1988-10-19
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H (K883649)Instrumentarium Corp.1988-10-19
BETA 3000M MOBILE NMR IMAGING SYSTEM (K883648)Fonar Corp.1988-10-19
OXOID INFECTIOUS MONONUCLEOSIS KIT (K883540)Unipath , Ltd.1988-10-19
ELAN-E DISPOSABLE DRAPE (K884057)Aesculap Instruments Corp.1988-10-19
AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) (K883915)Immco Diagnostics, Inc.1988-10-19
STERILE DISPOSABLE SURGICAL PACKS (K884093)Bolden Surgical Products1988-10-19
DIACARE MONITORING SYSTEM (K882001)Healthware Corp.1988-10-18
CLOSED WOUND SUCTION DEVICE (K883472)Westmark, Sterile Packing Systems, Inc. (Sps)1988-10-18
ULTRACARE (K883633)Jobst Institute, Inc.1988-10-18
INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM (K883719)Biophysic Medical, Inc.1988-10-18
LUMINBOND, BONDING AND CEMENTATION SYSTEM (K883392)Scientific Pharmaceuticals, Inc.1988-10-18
QUIDEL ALLERGY SCREEN (K883666)Quidel Corp.1988-10-18
NEBULIZER PUMP POWERED MODELS 020 AND 050 (K883132)Travelneb, Inc.1988-10-18
DENTAL ANTI-SNORING DEVICE (K874416)Ortho Publications, Inc.1988-10-18
DISPOSABLE AMNIOTOME (K883283)Galenica Enterprises, Inc.1988-10-18
NICOLET EPIDURAL SPINAL ELECTRODE (K882053)Nicolet Instrument Corp.1988-10-18
ARTERIAL ANCHOR BANDAGE (K883957)Guidelines, Inc.1988-10-18
DANTEC MAGNETIC STIMULATOR (K881915)Dantec Electronics, Inc.1988-10-17
STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES (K884211)Marquette Medical, Inc.1988-10-17
SINGLE-FIL(TM) SYRINGE (K883955)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-17
CARDIOMEGA-T (K883410)Grandcor Medical Systems1988-10-17
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER (K883436)Ppg Industries, Inc.1988-10-17
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER (K884023)Cardiac Control Systems, Inc.1988-10-17
WINGED NON-CORING NEEDLE SET (K884212)Marquette Medical, Inc.1988-10-17
BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P (K883819)Circon Acmi1988-10-17
MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD (K883265)Telectronics and Cordis Pacing Systems1988-10-14
AIR PLETHYSMOGRAPH MODEL APG-1000 (K881291)Aci Medical, Inc.1988-10-14
POLYSAFE(TM) IMPLANTABLE PACING LEAD (K884024)Cardiac Control Systems, Inc.1988-10-14
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE (K883174)Baxter Healthcare Corp1988-10-14
BLOOD PRESSURE CUFF (K881799)Biomedical Dynamics, Inc.1988-10-14
PORTABLE II DENTAL DELIVERY SYSTEM (K883775)Dntl Corp.1988-10-14
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS (K883091)Sharplan Lasers, Inc.1988-10-14
ACS INDEFLATOR P/T 20 (K883452)Advanced Cardiovascular Systems, Inc.1988-10-14
PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE (K881456)Laboratoire Ccd C/O Washington Regulatory Services1988-10-14
MULTI-DRUG INFUSION SYSTEM (K883003)I-Flow Corp.1988-10-14
ULTRAFLOTATION BED (K882607)Medical Flotation Systems, Inc.1988-10-14
TOWNLEY COX COMB ACETABULAR COMPONENT (K882869)Biopro, Inc.1988-10-14
STERILE SURGICAL LATEX GLOVES (K883824)Intl. Trading Ventures, Inc.1988-10-13
MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 (K884039)Medical Dynamics, Inc.1988-10-13
MEDTRONIC MODEL 4951P (K881810)Medtronic Vascular1988-10-13
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY (K883927)Ciba Corning Diagnostics Corp.1988-10-13
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION (K882758)3M Health Care, Sarns1988-10-13
VFQ HEAD COIL (K883737)Resonex, Inc.1988-10-13
RUBBER BAND, STERILE (K882695)Bioseal1988-10-13
CARETEX OR TOWEL (K884112)James River Corp.1988-10-13
ALM OPERATING TABLES (K884019)Alm Surgical Equipment, Inc.1988-10-13
VISION CREATINE KINASE (K883946)Abbott Laboratories1988-10-13
PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT (K883221)Pioneering Technologies, Inc.1988-10-13
STERI-TAG(TM) STERILE LABEL SETS (K883654)Acacia Laboratories, Inc.1988-10-13
ALLOPREP SYSTEM (K883065)Osteotech, Inc.1988-10-13
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR (K883092)Bennett X-Ray Corp.1988-10-13
EP-STAT (K883152)Coherent Systems, Inc.1988-10-13
INTER TRON 4000 (K880924)Diversified Chiropractic Systems1988-10-13
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY (K882560)Ciba Corning Diagnostics Corp.1988-10-13
SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 (K884092)Surgilase, Inc.1988-10-13
INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM (K883439)Medtronic Blood Systems, Inc.1988-10-13
TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM (K883358)Telescan Medical Systems1988-10-13
TECHNICON RA(TM) SYSTEMS - MAGNESIUM (K883326)Technicon Instruments Corp.1988-10-13
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (K883387)Tech-Co, Inc.1988-10-13
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST (K883861)Casco Standards1988-10-13
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING (K883921)Osteonics Corp.1988-10-13
LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) (K884073)Eastmed Enterprises, Inc.1988-10-13
PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM (K883082)Deknatel, Inc.1988-10-13
ARTHRO-TRAC(TM) (K883361)Rudolph Beaver, Inc.1988-10-13
LTDT PATIENT LIFTER (K884110)Devine Medical Products1988-10-13
NOVASPEC II SPECTROPHOTOMETER (K883435)Pharmacia, Inc.1988-10-13
SURGI-TAG(TM) STERILE LABEL SETS (K884055)Acacia Laboratories, Inc.1988-10-13
CASF CANCELLOUS BONE SCREW, BT650 (K882934)Terray Manufacturing, Inc.1988-10-13
THERMO-BODY-WRAP SYSTEM (K881862)Thermo Body Wrap Systems, Inc.1988-10-13
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