Atlas FDA

1996

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

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RecordFirmDate
VIDAS ESTRADIOL II (E2II) ASSAY (K955647)Biomerieux Vitek, Inc.1996-02-06
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST (K952517)Quidel Corp.1996-02-06
PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM (K952687)ETHICON, Inc.1996-02-06
CLARUS SPINEPEN MODEL 2126 (K955598)Clarus Medical Systems, Inc.1996-02-06
ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG (K954282)Statcorp, Inc.1996-02-06
THE AIRCEL SYSTEM (K954593)Marcon Group, Inc.1996-02-06
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (K955238)Rusch Intl.1996-02-06
DRYSLIDE CARTARRHALIS (K954783)Difco Laboratories, Inc.1996-02-06
HSW GMBH HYSTEROSCOPES & ACCESSORIES (K952186)Henke-Sass, Wolf GmbH1996-02-06
MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 (K955896)Critical Device Corp.1996-02-06
NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR (K952847)Ace Surgical Supply Co., Inc.1996-02-06
IMTEC BIOBARRIER (K950306)Imtec Corp.1996-02-06
IMMULITE TOTAL TESTOSTERONE (K955870)Diagnostic Products Corp.1996-02-06
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) (K953968)Aesculap, Inc.1996-02-05
3M NO STING BARRIER FILM (K955103)3M Medical Products Group1996-02-05
SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER (K953585)Schwartz Electro-Optics, Inc.1996-02-05
SORBIE TOTAL ELBOW SYSTEM (K955099)Wrightmedicaltechnologyinc1996-02-05
GENERAL USE SYNTHETIC SPONGE (STERILE) (K955527)Igenics, Inc.1996-02-05
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (K954898)Genzyme Corp.1996-02-05
QBC ACCUREAD SYSTEM (K955504)Becton Dickinson Diagnostic Instrument Systems1996-02-05
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION) (K954727)Surgical Laser Technologies, Inc.1996-02-05
SIEMENS SC 9000 ETCO2 MODULE (K954632)Siemens Medical Solutions USA, Inc.1996-02-05
ACCESS PROGESTERONE ASSAY (K955769)Bio-Rad Laboratories, Inc.1996-02-05
IAMIN GEL WOUND DRESSING (K953853)Procyte Corp.1996-02-05
CANDELA CRYO-PROBE HOLDER (K954872)Candela Laser Corp.1996-02-05
IL TEST CHOLINESTERASE (K943367)Instrumentation Laboratory CO1996-02-05
SYNTHETIC SPONGE (K955165)Igenics, Inc.1996-02-05
LYPHOCHEK BENZO/TCA CONTROL-SET B (K955153)Bio-Rad1996-02-05
FMS ARTHOPROBE (K955500)Future Medical Systems, Inc.1996-02-05
GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM (K953274)Smith & Nephew Richards, Inc.1996-02-05
HEARING AID IMPRESSION MATERIAL (K955288)Crown Delta Corp.1996-02-02
SAS SALMONELLA H R ANTISERUM (K955194)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H T ANTISERUM (K955192)Sa Scientific, Inc.1996-02-02
RESOUND PERSONAL HEARING SYSTEM BT247 (K955867)Resound Corp.1996-02-02
SAS SALMONELLA H POLY C ANTISERUM (K955198)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H POLY B ANTISERUM (K955199)Sa Scientific, Inc.1996-02-02
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE (K953564)Medtronic Cardiac Surgery, Medtronic, Inc.1996-02-02
SAS SALMONELLA H L,Z13 ANTISERUM (K955203)Sa Scientific, Inc.1996-02-02
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION (K955260)Nova Biomedical Corp.1996-02-02
PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS (K951246)Protocol Systems, Inc.1996-02-02
SAS SALMONELLA H L,V ANTISERUM (K955205)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H L,Z40 ANTISERUM (K955202)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H G,M ANTISERUM (K955209)Sa Scientific, Inc.1996-02-02
OPTUS OTOSCOPES (K945264)Optus, Inc.1996-02-02
SAS SALMONELLA H X ANTISERUM (K955191)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H L,W ANTISERUM (K955204)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H Z6 ANTISERUM (K955188)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H Y ANTISERUM (K955190)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H I ANTISERUM (K955207)Sa Scientific, Inc.1996-02-02
TEE PROBE (K953579)Biosound, Inc.1996-02-02
SAS SALMONELLA H S ANTISERUM (K955193)Sa Scientific, Inc.1996-02-02
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 (K955264)Nova Biomedical Corp.1996-02-02
HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES (K954294)Thermotrex Corp.1996-02-02
SS102 DUAL CHANNEL SEP STIMULATOR (K955257)Axon Systems, Inc.1996-02-02
SAS SALMONELLA H Z4, Z23 ANTISERUM (K955187)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H POLY A ANTISERUM (K955200)Sa Scientific, Inc.1996-02-02
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD (K955801)Terumo Medical Corp.1996-02-02
SAS SALMONELLA H H ANTISERUM (K955208)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H K ANTISERUM (K955206)Sa Scientific, Inc.1996-02-02
JPI INTENSIFYING SCREEN (K954161)Jpi Healthcare Co, Ltd.1996-02-02
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 (K955252)Nova Biomedical Corp.1996-02-02
FINETONE FSC, (K955692)Finetone Hearing Instruments1996-02-02
SAS SALMONELLA H F,G, ANTISERUM (K955210)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H Z29 ANTISERUM (K955186)Sa Scientific, Inc.1996-02-02
VARIAN MULTILEAF COLLIMATOR (K943224)Varian Assoc., Inc.1996-02-02
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE (K954934)Candela Laser Corp.1996-02-02
BRAINLAB STEROTATIC HEADRING (K952390)Brainlab Med. Computersysteme GmbH1996-02-02
SAS SALMONELLA H Z ANTISERUM (K955189)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H,M,T, ANTISERUM (K955201)Sa Scientific, Inc.1996-02-02
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (K950481)Isolab, Inc.1996-02-01
HANAULUX BLUE 30 & 80 (K954169)Heraeus Med GmbH1996-02-01
DEPUY VISION AML HIP PROTHESIS (K953694)Depuy, Inc.1996-02-01
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (K954848)Meadox Medicals, Div. Boston Scientific Corp.1996-02-01
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) (K954714)Pacesetter, Inc.1996-02-01
VALLEYLAB COATED ELECTRODES (K955836)Valleylab, Inc.1996-02-01
DEPUY VISION SOLUTION HIP PROSTHESIS (K953703)Depuy, Inc.1996-02-01
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K955364)W. L. Gore & Associates, Inc.1996-02-01
RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (K955683)Contour Fabricators of Florida, Inc.1996-02-01
OTV-S5 OES VIDEO SYSTEM (K955404)Olympus America, Inc.1996-02-01
P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT (K953202)Johnson & Johnson Professionals, Inc.1996-01-31
ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT (K952859)Johnson & Johnson Professionals, Inc.1996-01-31
TRILASE 2940 ERBIUM LASER (K954013)Schwartz Electro-Optics, Inc.1996-01-31
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS (K953925)Biomet, Inc.1996-01-31
RESPIRONICS MONARCH MINI MASK (K945938)Respironics, Inc.1996-01-31
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET (K954835)Holgrath Medical Technologies, Inc.1996-01-31
OLYMPUS URIC ACID REAGENT (K955752)Olympus America, Inc.1996-01-31
RIM FLARE ACETABULAR COMPONENT (K955033)Intermedics Orthopedics1996-01-31
MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER (K955111)Adam Spence Corp.1996-01-31
LACTOSORB SUTURE ANCHOR (K954443)Poly-Medics,Inc.1996-01-31
MICROSURGE THORACOSCOPIC INSTRUMENTS (K955408)Microsurge, Inc.1996-01-31
X6000D SILENT SUN LIGHT SOURCE (K955510)Products For Medicine1996-01-31
MODEL 7355 (K952491)Devilbiss Health Care, Inc.1996-01-31
MITEK THREADED ANCHOR (FASTIN) (K953560)Mitek Surgical Products, Inc.1996-01-31
AT-III CONTROL PLASMA KIT (K955040)American Bioproducts Co.1996-01-31
ACE-DUPONT COMPOSITE RINGS (K955388)Ace Medical Co.1996-01-31
GEL MASK (K954207)Respironics, Inc.1996-01-31
BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK (K955003)Bioscience, Inc.1996-01-31
ILLUMINATOR (K954787)Hospitak, Inc.1996-01-31
PROFIX POSTERIOR-STABILIZED KNEE SYSTEM (K954909)Smith & Nephew Richards, Inc.1996-01-31
ULTIMA SIZE 0 CEMENTED FEMORAL STEM (K953200)Johnson & Johnson Professionals, Inc.1996-01-31
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