Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DSL ACTIVE I-HCG ELISA (K961911)Diagnostic Systems Laboratories, Inc.1996-06-28
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE (K955564)Rusch, Inc.1996-06-28
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM (K960053)Selfcare, Inc.1996-06-28
R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM (K961496)Howmedica, Inc.1996-06-28
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD (K961010)Princeton BioMeditech Corp.1996-06-28
ULTRACUT 2000 (K960374)Ultralase Technologies, Inc.1996-06-28
MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1 (K961238)Toshiba America Mri, Inc.1996-06-28
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS (K961433)Electro-Biology, Inc.1996-06-28
LXN BLOOD GLUCOSE TEST SYSTEM (K960034)Lxn Corp.1996-06-28
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE (K953805)Abbott Laboratories1996-06-28
RESPOSABLE INFANT RESUSCITATOR (K961882)Medical Marketing Concepts1996-06-28
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (K960173)Gabriel Medical, Inc.1996-06-27
USCI COMMANDER SERIES GUIDE WIRES (K961271)C.R. Bard, Inc.1996-06-27
SHARPS-TAINER (K961878)Winfield Industries1996-06-27
PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE (K961267)Pioneer Surgical Technology1996-06-27
DELTATALKER WITH INFRARED (K961306)Prentke Romich Co.1996-06-27
ACCUMETER H. PYLORI TEST (K960478)Chemtrak, Inc.1996-06-27
EASTERCLAVE (K961230)Easter Services, Inc.1996-06-27
COMFIT (K953590)Wembley Rubber Products (M) Sdn Bhd1996-06-27
CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 (K961690)Continental X-Ray Corp.1996-06-27
LASER PERIPHERALS INC. BARE FIBER (K961516)Laser Peripherals, LLC1996-06-27
RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY (K961840)Rusch Intl.1996-06-27
PHILIPS EASYVISION (K953911)Philips Medical Systems, Inc.1996-06-27
PUNCTUR-GUARD WINGED SET (K961251)Bio-Plexus, Inc.1996-06-27
INDEX SHOE (K960307)Orthopedic Technology Research, Inc.1996-06-27
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE (K955495)Rusch, Inc.1996-06-27
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES) (K961310)Storz Instrument Co.1996-06-27
CEDIA THEOPHYLLINE ASSAY (K961462)Boehringer Mannheim Corp.1996-06-27
LIBERTY LITE PFS SYSTEM (K960496)Utah Medical Products, Inc.1996-06-27
SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE (K955918)Sinochem Ningbo Imp & Exp Corp.1996-06-27
SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES (K960746)Sunmax Enterprise Shanghai Co. , Ltd.1996-06-27
MX960 REUSABLE PRESSURE TRANSDUCER (K961404)Medex, Inc.1996-06-27
BONESOURCE HYDROXYAPATITE CEMENT (HAC) (K953339)Osteogenics, Inc.1996-06-27
DANESHVAR'S DEVICE (MODIFICATION) (K961461)Y. Daneshvar1996-06-26
THERMACYL BLOOD/FLUID WARMER (K953741)Baxter Healthcare Corp1996-06-26
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (K961295)Sil-Med Corp.1996-06-26
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE (K961495)Baxter Healthcare Corp1996-06-26
CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 (K942867)Clearwater Colon Hydrotherapy, Inc.1996-06-26
MPM HYDROGEL DRESSING (NON-STERILE) (K962160)Mpm Medical., Inc.1996-06-26
VIVAGLASS CEM (K962297)Ivoclar North America, Inc.1996-06-26
EVRON GEL (K961222)Pharmaceutical Innovations, Inc.1996-06-26
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET (K962165)Roche Diagnostic Systems, Inc.1996-06-26
SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM (K961421)Synthes (Usa)1996-06-26
MAESTRO CLINICAL REMOTE CONTROL (K954572)Respironics, Inc.1996-06-26
RHEUMATOID FACTOR LATEX SLIDE TEST KIT (K961169)Randox Laboratories, Ltd.1996-06-26
QUICKSPLINT (K961995)Heraeus Kulzer, Inc.1996-06-26
0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP (K961232)Biocompatibles , Ltd.1996-06-26
VIVAGLASS FIL (K961910)Ivoclar North America, Inc.1996-06-26
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE (K961494)Micro-Mega Societe Anonyme1996-06-26
VITROS SPECIALTY DILUENT (K962235)Johnson & Johnson Clinical Diagnostics, Inc.1996-06-26
CIBA CORNING 400 SYSTEM (K961657)Ciba Corning Diagnostics Corp.1996-06-25
SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO (K953948)Futuremed America, Inc.1996-06-25
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER (K961390)Ethicon Endo-Surgery, Inc.1996-06-25
RNS ARTHROGRAM TRAY (K962040)Contour Fabricators of Florida, Inc.1996-06-25
HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM (K955853)Healthcare Service and Supply1996-06-25
BOSWORTH TEMPORARY RESIN (K961199)Harry J. Bosworth Co.1996-06-25
GE STERILE ARTHROGRAM TRAY (K962035)GE Medical Systems1996-06-25
SURE CHECK PREGNANCY TEST (K961965)Chembio Diagnostic Systems, Inc.1996-06-24
ES-3840, VIDEO SIGMOIDOSCOPE (K961567)Pentax Precision Instrument Corp.1996-06-24
CIBA CORNING 348 SYSTEM (K962021)Ciba Corning Diagnostics Corp.1996-06-24
PANASIL IMPRESSION MATERIAL (K954281)Roydent Dental Products, Inc.1996-06-24
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH) (K961570)Pentax Precision Instrument Corp.1996-06-24
LAMINOSS DENTAL IMPLANT (K933705)Impladent , Ltd.1996-06-24
STERILIZATION (K943657)Telectronics Pacing Systems, Inc.1996-06-24
SYPHILIS IGM HUMAN SERUM CONTROLS (K961317)Pyramid Biological Corp.1996-06-24
DALL-MILES STAINLESS STEEL BEADED CABLE (K961569)Howmedica Corp.1996-06-24
BIODATA TESTOSTERONE MAIA KIT (K955102)Biochem Immunosystems (U.S.), Inc.1996-06-24
MAGNETO EYEWEAR (K962169)Nike, Inc.1996-06-24
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER (K961326)Medica Corp.1996-06-21
ECG MONITOR MODEL DS-3130/3140 (K961174)Hitachi Medical Systems America, Inc.1996-06-21
DISPOSABLE ECG ELECTRODE (K953649)Kendall-Ltp1996-06-21
CALIBRATION SERUM LEVEL 1 & 2 (K955489)Randox Laboratories, Ltd.1996-06-21
TRANSAMERICA ELECTRODE (K961749)Transamerica Medical Systems1996-06-21
NMI VEIN GRAFT PERFUSION SET (K961181)Naltiac Medical, Inc.1996-06-21
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 (K961282)Diagnostic Chemicals , Ltd.1996-06-21
ACS CKMB II IMMUNOASSAY (K962126)Ciba Corning Diagnostics Corp.1996-06-21
WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION) (K960978)Wrightmedicaltechnologyinc1996-06-21
PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER (K961853)Acufex Microsurgical, Inc.1996-06-21
HANDSAFE (K960386)Handsafe Products Sdn. Bhd.1996-06-21
K-Y PERSONAL LUBRICANT (K955648)Ortho Pharmaceutical Corp.1996-06-21
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE (K954514)Sciteck Diagnostics, Inc.1996-06-21
NMI ANTEGRAD CARDIOPLEGIA CANNULA (K961180)Naltiac Medical, Inc.1996-06-21
URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY (K962073)Continental Medical Laboratories, Inc.1996-06-21
ACS LH2 IMMUNOASSAY (K962041)Ciba Corning Diagnostics Corp.1996-06-21
IMMULITE HERPES I AND II IGG (K950670)Diagnostic Products Corp.1996-06-21
HUMPHREY OCT SCANNER (K961171)Carl Zeiss, Inc.1996-06-21
PERCUTANEOUS INTRODUCER SYSTEM (K961219)Boston Scientific Corp1996-06-21
IMPACT (K961694)Matrix Technologies Corp.1996-06-21
KNOW-RECIRC (K953551)H&H Control Systems1996-06-21
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET (K961225)Baxter Healthcare Corp1996-06-21
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) (K961436)Roche Diagnostic Systems, Inc.1996-06-21
SELECTONE UNIVERSAL PLUS MUNRO LAPAROSCOPIC LOOP ELECTRODE MODEL 60-5276 SERIES (K961197)Conmedcorp1996-06-21
FENNING FEMORAL COMPONENT (K960303)Biomet, Inc.1996-06-21
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM (K961337)Medisense, Inc.1996-06-21
LUMISCOPE MODEL 2018 THERMOMETER (K954792)Lumiscope Co., Inc.1996-06-21
AMYLASE (ETHYLIDENE PNGPG7) KIT (K953211)Randox Laboratories, Ltd.1996-06-21
THYROGLOBULIN ANTIBODY ELISA (K960370)Immco Diagnostics, Inc.1996-06-20
AUTOVAC BP SYSTE, 2000 SERIES (K955010)Boehringer Laboratories1996-06-20
MORE-L INJECTOR KIT PLUS (K960619)Incutech, Inc.1996-06-20
ULTIMATE SEAL (K960401)Hans Rudolph, Inc.1996-06-20
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Every clearance here is in the API, with alerts when new ones post.