Atlas FDA

1988

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

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RecordFirmDate
PERFORMED CROWN (STAINLESS STEEL) (K883325)Whitecap Dental Co.1988-09-16
INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110 (K883650)Instrumentarium Corp.1988-09-16
INTERSEPT*PREBYPASS FILTER (K883086)Medtronic Blood Systems, Inc.1988-09-16
BARO-GRAF 24 (K881297)Instromedix, Inc.1988-09-16
SCIMED R30 SILICONE ASSIST RESERVOIR (K882720)Scimed Life Systems, Inc.1988-09-16
PROCEDURE PACKS SOLUTION ADMINISTRATION SETS (K882716)Procedure Packs, Inc.1988-09-16
VITEK GRAM-NEGATIVE IDENTIFICATION CARD (K883558)Vitek Systems, Inc.1988-09-16
KOMET SURGICAL BUR (K883255)Komet Medical, Div. of Brasseler USA I, L.P.1988-09-15
OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (K883613)Stierlen-Maquet AG1988-09-15
CANON IOL ESTIMATOR KU-1 (K881889)Canon USA, Inc.1988-09-15
HERAEUS C SPECIAL (K883507)Degussa Dental, Inc.1988-09-15
VITRABOND LIGHT CURE GLASS IONOMER LINER (K882821)3M Company1988-09-15
EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM (K882605)Buckman Co., Inc.1988-09-15
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) (K883213)Nidek, Inc.1988-09-15
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI. (K882556)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-15
SUNGLASSES, IMPORTED (K883771)Norcon, Inc.1988-09-15
COUNT-A-DOSE (K883311)Pavel Jordan & Associates, Inc.1988-09-15
CYTOGUARD(R) (K883614)Survival Technology, Inc.1988-09-15
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM (K883199)Chiron Vision Corp.1988-09-15
SITE MACROBORE PHACO NEEDLE (K883099)Site Microsurgical Systems, Inc.1988-09-15
DEGUPAL 4 (K883510)Degussa Dental, Inc.1988-09-15
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS (K881811)Cobe Laboratories, Inc.1988-09-15
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR (K882721)Hear-O Inc. C/O L.P. Leale & Assoc.1988-09-15
SKID RESISTANT, LONG LASTING SHOE COVERS (K883657)James River Corp.1988-09-15
DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM (K883072)Siemens Gammasonics, Inc.1988-09-14
INSTRUMENTARIUM ULF MR IMAGING SYSTEM (K883622)Instrumentarium Corp.1988-09-14
MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS (K881478)Keymed (Medical & Industrial Equipment), Ltd.1988-09-14
OMEGA NV(TM) BALLOON DILATATION CATHETER (K882052)Cook, Inc.1988-09-14
BREAST LESION LOCALIZATION NEEDLE (K881697)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-14
PROLOG MP 658M PULSE GENERATOR (K883087)Pacesetter Systems1988-09-14
SHIMADZU LATERAL C-ARM MH-31 (K882311)Shimadzu Precision Instruments, Inc.1988-09-14
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) (K883434)Ambu, Inc.1988-09-14
COULTER CLONE B1 MONOCLONAL ANTIBODY (K882557)Coulter Immunology1988-09-14
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE (K870722)National Medical Care, Medical Products Div., Inc.1988-09-14
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716 (K882394)Medtronic Vascular1988-09-14
PRL-QUANT (K883269)Leeco Diagnostics, Inc.1988-09-13
FILLING VOLUME OPTION (K882295)Eris Medical Technology1988-09-13
STRYKER PRESSURE MONITOR SYSTEM (K883485)Stryker Corp.1988-09-13
4007 MODEL RECLINER CONTROLLER (K883678)Rolcontrol Products, Co., Inc.1988-09-13
DURAZYME(R) CPK (K883504)American Monitor Corp.1988-09-13
THORACIC CATHETERS (K883474)Westmark, Sterile Packing Systems, Inc. (Sps)1988-09-13
COMPAT (R) ENTERAL DELIVERY SYSTEM (K882218)Sandoz Nutrition1988-09-13
IQ HDL CHOLESTEROL (K883353)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-13
STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT (K875280)Steris C/O Medical Device Consultants, Inc.1988-09-13
HANDSWITCHING MONOPOLAR PENCIL (K883396)New England Surgical Instrument Corp.1988-09-13
URIC ACID REAGENT (PRODUCT #88219) (K883404)Hichem Diagnostics1988-09-13
TRIGLYCERIDES REAGENT (PRODUCT #88218) (K883405)Hichem Diagnostics1988-09-13
PARALYZED VETERANS OF AMERICA POWER RECLINER (K883672)Rolcontrol Products, Co., Inc.1988-09-13
VENTREX COATED TUBE TSH (K883342)Ventrex Laboratories, Inc.1988-09-13
VISION(R) PROTHROMBIN TIME (K883441)Abbott Laboratories1988-09-13
TECHNICON RA-100(TM) SYSTEM (K883209)Technicon Instruments Corp.1988-09-13
POWER MECHANICAL RECLINER (K883673)Rolcontrol Products, Co., Inc.1988-09-13
OPMI CS (K883581)Carl Zeiss, Inc.1988-09-13
EMAX PRECISION MICROPLATE READER (K883302)Molecular Devices Corp.1988-09-13
BIOTROL URIC ACID ENZYMATIQUE TRINDER (K883428)Biotrol, USA, Inc.1988-09-13
WHEELS-OFF QUICK RELEASE AXLE SYSTEM (K883679)Rolcontrol Products, Co., Inc.1988-09-13
LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL (K883247)Quantimetrix Medical Industries1988-09-13
FRESENIUS F8 DIALYZER (K883195)Fresenius USA, Inc.1988-09-13
S 21 INSTRUMENT STAND (K883578)Carl Zeiss, Inc.1988-09-13
MANUAL SWING ARM (K883674)Rolcontrol Products, Co., Inc.1988-09-13
PUNCH MYRINGOTOMY SYSTEM (K882689)Xomed, Inc.1988-09-13
805 POWER CHAIR CONVERSION SYSTEM (K883671)Rolcontrol Products, Co., Inc.1988-09-13
MRM GASTROSTOMY BELT (K882089)Mrm Products, Inc.1988-09-13
MX860, REUSABLE PRESSURE TRANSDUCER (K883095)Medex, Inc.1988-09-12
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 (K882476)Ela Medical, Inc.1988-09-12
TRU-TRAC TORQUE GUIDEWIRE (K880288)N-S Medical Products1988-09-12
RAYMAX 2100 MODELS 2130 & 2136 (K883431)Raymax Medical Corp.1988-09-12
MULTINEX MONITOR (MODIFICATION) (K883254)Datascope Corp.1988-09-12
COLLAGEN SHIELD (K882762)Chiron Ophthalmics1988-09-12
HEARTSTART 1000 (K883341)Laerdal Mfg. Corp.1988-09-12
PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) (K882879)Pioneering Technologies, Inc.1988-09-12
BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (K881049)Microline Pentax, Inc.1988-09-12
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL (K881469)Baxter Healthcare Corp1988-09-12
HEARTSTART 1000S (K883344)Laerdal Mfg. Corp.1988-09-12
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE (K883575)Site Microsurgical Systems, Inc.1988-09-12
TRU-TRAC COILED GUIDEWIRE (K880287)N-S Medical Products1988-09-12
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 (K882474)Ela Medical, Inc.1988-09-12
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 (K882506)Span-America Medical Systems, Inc.1988-09-09
MODEL AU-1 ACCESSORY UNIT (K882926)Directed Energy, Inc.1988-09-09
PHASE II FSH KIT (K883279)Vitek Systems, Inc.1988-09-09
GESCO CATHETERIZATION TRAY (K882647)Gesco Intl., Inc.1988-09-09
KTP/YAG(TM) SURGICAL LASER (K882734)Laserscope1988-09-09
URINE TOXICOLOGY STANDARD (K881320)Verichem Laboratories, Inc.1988-09-09
A.QC CHEMISTRY CONTROL LEVEL 2 (K883012)Arden Medical Systems, Inc.1988-09-09
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1 (K881616)Progress Mankind Technology1988-09-09
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5 (K883459)Diagnostic Products Corp.1988-09-09
PREGNAGEN(TM) (K882002)Biogenex Laboratories1988-09-09
ALTLTS ALANINE AMINO TRANSFERASE ALT (K883205)Electro-Nucleonics, Inc.1988-09-09
MINIM-X 2001-CIAS & MINIM-X 2002-CIAS (K882379)Dentomar, Inc.1988-09-09
OPHTHALMIC PAO VALVE (K882536)Look, Inc.1988-09-09
OPHTHALMIC FLUID INJECTOR (K882403)Trek Medical Products, Inc.1988-09-09
STAT FAX(TM) (K882938)Awareness Technology, Inc.1988-09-09
BLOOD GAS MIXTURE (K882941)Swisco, Inc.1988-09-09
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (K883085)Serono Diagnostics, Inc.1988-09-09
LACTATE DEHYDROGENASE LDH (K883206)Electro-Nucleonics, Inc.1988-09-09
BIODYNAMICS AUTOTRANSFUSION RESERVOIR (K881631)Biodynamics Corp.1988-09-09
DADE TDM CONTROL (K883190)Baxter Healthcare Corp1988-09-09
ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL (K882477)Pasco Laboratories, Inc.1988-09-08
MYOCARD BIOPSY FORCEP (K881412)Fehling Medizintechnik GmbH1988-09-08
RADKOR SFC-21 (K881701)Radkor, Inc.1988-09-08
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Track 1988 automatically

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