Atlas FDA

1988

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

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RecordFirmDate
PROFORMA HIP SYSTEM (K883941)Orthomet, Inc.1988-11-30
ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION (K873826)Acromed Corp.1988-11-30
RESUBMITTED EMA DENTIN CEMENT (K883770)G-C Intl. Corp.1988-11-30
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER (K883964)Baxter Healthcare Corp1988-11-30
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (K883836)Coulter Immunology1988-11-30
SHOULDER TRANSMIT AND RECEIVE COILS (K884603)Diasonics, Inc.1988-11-30
EDWARDS ARTHROSCOPIC LEG HOLDER (K884302)Baxter Healthcare Corp1988-11-30
SONY CINE VIDEO SYSTEM SME-3300 (K884008)Sony Medical Electronics Co.1988-11-30
MQL 20 ND:YAG OPHTHALMIC LASER (K884694)California Laboratories, Inc.1988-11-30
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR (K884056)Xomed, Inc.1988-11-30
MT/S CARLSON SPINE COIL, PART # 100-50082500-01 (K884604)Diasonics, Inc.1988-11-30
XTREL, MODEL NUMBER 3425 (K883780)Medtronic Vascular1988-11-30
RANEY CLIP (K884783)Alto Development Corp.1988-11-30
SUBOCCIPITAL ICE PILLOW (K882413)Ferguson Medical1988-11-30
FLO-RESTER (K883696)Bio-Vascular, Inc.1988-11-30
GE MR MAX SYSTEM (K883547)General Electric Co.1988-11-30
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED (K884517)Kallestad Diag, A Div. of Erbamont, Inc.1988-11-30
H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER (K883177)Texas Intl. Laboratories, Inc.1988-11-30
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES (K883745)Diagnostic Products Corp.1988-11-30
ALPHACALF SERUM (K884654)Hyclone Laboratories, Inc.1988-11-30
DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES (K883461)Biohm, Inc.1988-11-30
ZINC OXIDE EUGENOL TEMPORARY CEMENT (K883698)E&D Dental Manufacturing Co.1988-11-29
TDX BENZODIAZEPINES SERUM (K883730)Abbott Laboratories1988-11-29
TECHNICON RA-100 SYSTEM POTASSIUM (K883586)Technicon Instruments Corp.1988-11-29
BIOTROL BILIRUBIN MONOREACTIF (K884480)Biotrol, USA, Inc.1988-11-29
HOME CLINIC PREGNANCY TEST (K883826)Vanguard Biomedical Corp.1988-11-29
TECHNICON ASSIST POTASSIUM (K883585)Technicon Instruments Corp.1988-11-29
CERVICAL BIOPSY INSTRUMENT (K883867)Mend Technologies, Inc.1988-11-29
MODEL 500V VASCULAR SPECTRUM ANALYZER (K882755)Multigon Industries, Inc.1988-11-29
TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER (K881303)Triton Technology, Inc.1988-11-29
GLASS IONOMER BASE (K882751)Dentsply Intl.1988-11-29
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD (K883890)E.I. Dupont DE Nemours & Co., Inc.1988-11-29
LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL (K884364)Bausch & Lomb Pharmaceutical, Inc.1988-11-29
ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. (K884168)The DU Pont Co.1988-11-29
TRANSESOPHAGEAL ECHO TRANSDUCER (K883889)General Electric Co.1988-11-29
LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL (K884363)Bausch & Lomb Pharmaceutical, Inc.1988-11-29
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER (K883891)E.I. Dupont DE Nemours & Co., Inc.1988-11-29
ROCHE REAGENT FOR INORGANIC PHOSPHORUS (K883962)Roche Diagnostic Systems, Inc.1988-11-29
ABBOTT IMX LH (K884138)Abbott Laboratories1988-11-29
ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY (K881140)Advanced Technology Laboratories, Inc.1988-11-29
TECHNICON ASSIST(R) CALCIUM METHOD (K884433)Technicon Instruments Corp.1988-11-29
LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD (K884362)Bausch & Lomb Pharmaceutical, Inc.1988-11-29
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM (K884369)General Electric Co.1988-11-28
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM (K883868)Fisher & Paykel Electronics , Ltd.1988-11-28
TRACER SKELETAL TRACTION PINS (K884407)De Medica Mfg., Inc.1988-11-28
HP-1 (HEALTHPAX) (K883812)Healthdirections, Inc.1988-11-28
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES (K882383)CIVCO Medical Instruments Co., Inc.1988-11-28
MULTIICHALLENGE NEBULIZER SYSTEM (K883704)Biotrine Corp.1988-11-28
TRACER HIP PINNING SYSTEM (K884406)De Medica Mfg., Inc.1988-11-28
O2 CARE (K882461)Ballard Medical Products1988-11-28
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT (K883372)Ausonics Pty , Ltd.1988-11-25
DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP (K884656)Dermacare1988-11-25
KTP/532 SURGICAL LASER (K884029)Laserscope1988-11-25
STERILE SURGICAL GLOVES (K883466)Cal-American Exports, Inc.1988-11-25
OCCU-TECH VISION TEST (K881971)Applied Vision Concepts, Inc.1988-11-25
PALMA (K882639)Kelso Imports1988-11-25
PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR (K884541)Pro-Vertic, Inc.1988-11-23
BERICHROM(R) ANTITHROMBIN III (K883662)Behring Diagnostics, Inc.1988-11-23
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR (K884638)Instrumentation Industries, Inc.1988-11-23
NIDEK LM-870 AUTOMATIC LENSMETER (K884188)Nidek, Inc.1988-11-23
ULTRASONIC IMAGING CATHETER (K883202)Boston Scientific Corp1988-11-23
VOXEL FLINGER(TM) 3-D IMAGING SYSTEM (K883476)Reality Imaging Corp.1988-11-23
DISKCAM DC 6001 (K884148)Camtronics, Ltd.1988-11-23
E.T. PUFFER (K884374)Kalajian Ent.1988-11-23
MAGNETOM (M, H, 42, 63) SEQUENCES (K884062)Siemens Medical Solutions USA, Inc.1988-11-23
POLYSCAN DIGITAL SCANNER (K882453)Medical and Scientific Enterprises, Inc.1988-11-23
NICOLET NYSTAR PLUS SYSTEM (K884294)Nicolet Instrument Corp.1988-11-23
NEEDLE EJECTOR (K881867)Howard, Hills & Harsh1988-11-22
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION (K884191)Baxter Diagnostics, Inc.1988-11-22
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT (K884194)Baxter Diagnostics, Inc.1988-11-22
FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 (K883822)Consolidated Industries of Greater Syracuse, Inc.1988-11-22
MODIFIED SLIDING RECONSTITUTION DEVICE (K884626)Baxter Healthcare Corp1988-11-22
MULTI-PURPOSE HOLDER (K884630)Med-Dex Intl.1988-11-22
PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT (K884193)Baxter Diagnostics, Inc.1988-11-22
MODIFICATION MIC/API UNISCEPT(R) (K884509)Analytical Products, Inc.1988-11-22
GHB SAMPLE PAPER (K880673)Isolab, Inc.1988-11-22
MSI-CAL 16 (K883850)Medical Specialties, Inc.1988-11-22
HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (K884573)Sigma Chemical Co.1988-11-22
TENSIOMETER (K883694)W. L. Gore & Associates, Inc.1988-11-22
ACCUTEMP PLUS (K881670)Sentry Medical Products, Inc.1988-11-22
TECHNICON RA-PHENOBARBITAL (K884419)Technicon Instruments Corp.1988-11-22
MSI-CAL 7 (K883703)Medical Specialties, Inc.1988-11-22
RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (K884572)Sigma Chemical Co.1988-11-22
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (K884192)Baxter Diagnostics, Inc.1988-11-22
MODIFICATION MICRO-MIC (K884510)Analytical Products, Inc.1988-11-22
LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT (K883212)Implant Technology, Inc.1988-11-22
MSI-CAL 8 (K883851)Medical Specialties, Inc.1988-11-22
DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (K884574)Sigma Chemical Co.1988-11-22
IMAGER (K883831)Fischer Imaging Corp.1988-11-21
NEOSOFT UMBILICAL VESSEL CATHETER (K883866)Menlo Care, Inc.1988-11-21
CARDIAC CX (K883985)Fischer Imaging Corp.1988-11-21
MODIFIED CONCHATHERM III CONTROLLED HEATER (K884150)Respiratory Care, Inc.1988-11-21
WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS (K883186)Wright Linear Pump, Inc.1988-11-21
ASD SINGLE LUMEN NEEDLE (K884620)Biosurge, Inc.1988-11-21
MODIFIED REFLUX REDUCER (K883818)Physician Engineered Products, Inc.1988-11-21
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL (K883872)Siemens Medical Solutions USA, Inc.1988-11-21
HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER (K883133)Ferguson Medical1988-11-21
SUNDERLAND NASAL TUBE (K883668)Exmoor Plastics , Ltd.1988-11-21
SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED (K884542)Commercial Products & Engineering Co.1988-11-21
VISTA MR 2055 HP SYSTEM (K883994)Philips Medical Systems (Cleveland), Inc.1988-11-21
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Every clearance here is in the API, with alerts when new ones post.