Atlas FDA

1996

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

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RecordFirmDate
PROD NO. 01-1694 - 4X4 FOAM DRESSING (K954728)Continental Medical Laboratories, Inc.1996-09-23
PRIME MODULAR ENDO HEAD (K962646)Orthopaedic Innovations, Inc.1996-09-23
SURESKIN STANDARD, BORDER, AND THIN (K963039)Euromed A/S1996-09-23
MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR (K962462)Smith and Nephew Donjoy, Inc.1996-09-23
AFFIRM ONE-STEP HOME PREGNANCY TEST (K962888)Athena Medical Corp.1996-09-23
DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES) (K963300)Lhasa Medical, Inc.1996-09-23
ACETAMINOPHEN FLEX REAGENT CARTRIDGE (K963244)Dade Intl., Inc.1996-09-23
DIGIPAN (K961826)Trophy Radiologie1996-09-23
MAMMARY SIZER (K961356)General Surgical Innovations1996-09-23
GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING (K963175)Glycar, Inc.1996-09-23
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN (K961522)Synvasive Technology, Inc.1996-09-23
AUTO SUTURE MODIFIED VCS CLIP APPLIER (K962043)United States Surgical, A Division of Tyco Healthc1996-09-23
ARTERIAL VENOUS BLOOD TUBING SET (K953823)Medisystems Corp.1996-09-23
HICHEM ALP/AMP REAGENT KIT (K963383)Hichem Diagnostics1996-09-23
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT (K963246)Medtronic Xomed1996-09-23
OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS (K962592)Alcon Laboratories1996-09-23
ECLIPSE VERSION 3.0 (K955577)Stellate Systems1996-09-20
TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS (K962465)Implant Innovations, Inc.1996-09-20
OHMEDA-OHIO CAE PLUS INCUBATOR (K962806)Ohmeda Medical1996-09-20
CHIPS POWERED WHEELCHAIR (K955548)International Healthcare Solutions, Inc.1996-09-20
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) (K960087)Wrightmedicaltechnologyinc1996-09-20
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES (K962986)Johnson & Johnson Medical, Inc.1996-09-20
CHIPS STANDUP WHEELCHAIR (K955547)International Healthcare Solutions, Inc.1996-09-20
FLUOROPLUS CARDIAC TV (K961140)Cmt Medical Technologies, Ltd.1996-09-20
ENDOBEAM (K963044)Corin USA1996-09-20
SIGNALDRESS (K962590)Convatec, A Division of E.R. Squibb & Sons1996-09-20
PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS (K961580)Sims Deltec, Inc.1996-09-20
ENDOSPOT (K963043)Corin USA1996-09-20
ESTEEM 1.5T MRI SYSTEM (K962677)Elscint Mr, Inc.1996-09-20
GUGLIELMI DETACHABLE COIL (K962503)Target Therapeutics1996-09-20
AURORA DIAGNOSTIC WORKSTATION (K962589)Aurora Technology, Inc.1996-09-20
SCARF THREAD-HEAD SCREW (K962236)Landos, Inc.1996-09-20
ASTHMA MONITOR (K960078)Erich Jaeger, Inc.1996-09-20
AXSYM CMV IGG ANTIBODY ASSAY (K953943)Abbott Laboratories1996-09-20
HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL (K963607)Midwest City Hearing Aid Center1996-09-20
COBE CENTRYSYSTEM 700 HG HEMODIALYZER (K962427)Gambro Healthcare1996-09-20
MICRO DIAMOND-POINT DISSECTION NEEDLES (K962544)Dsp Worldwide1996-09-20
SCION SAPHENOUS VEIN HARVESTING SYSTEM (K963006)Scion International, Inc.1996-09-20
STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH (K960024)Storz Instrument Co.1996-09-20
KODAK DIGITAL SCIENCE REMOTE CASSETTE (K962896)Eastman Kodak Company1996-09-20
TBAN (K963252)Boston Scientific Corp1996-09-20
PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE (K962494)Usbiomaterials Corp.1996-09-20
STEP OPTION TO PRISM 2000 (K960865)Philips Medical Systems (Cleveland), Inc.1996-09-20
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE (K961716)Ideas For Medicine, Inc.1996-09-19
CONTRAST INJECTION LINES (K960674)B.Braun Medical, Inc.1996-09-19
VITALITY HIP STEM (K962560)Encore Orthopedics, Inc.1996-09-19
TSH (MICROWELL) ELISA (K962216)Biomerica, Inc.1996-09-19
AMO PRESTIGE DAY PACK (ALLERGAN, INC.) (K962402)Allergan, Inc.1996-09-19
ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM (K962525)Morwel Corp.1996-09-19
PRIMALOC CEMENTED HIP SYSTEM (K962448)Ortho Development Corp.1996-09-19
ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE (K962692)Zomed Intl.1996-09-19
ON.SITE ALCOHOL (K963197)Ansys, Inc.1996-09-19
SAFETY VEST (K962429)Johnson & Johnson Professionals, Inc.1996-09-18
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE (K960061)Storz Instrument Co.1996-09-18
PROSPORE(STEARO FOR STEAM STERILIZER) (K962441)Raven Biological Laboratories, Inc.1996-09-18
10B ARGININE BROTH (K961046)Remel, L.P.1996-09-18
GONOPOX TEST KIT (K960759)Medtex Laboratories, Inc.1996-09-18
FLEX NEEDLE (K961049)Lighthouse Medical, Inc.1996-09-18
CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER (K953663)Cordis Webster, Inc.1996-09-18
RYDER LACRIMAL INTUBATIONSET (K962151)Ryder Intl. Corp.1996-09-18
SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M (K960754)Mecta Corp.1996-09-18
ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY) (K963157)Oratec Interventions, Inc.1996-09-18
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K962843)Starplex Scientific, Inc.1996-09-18
FLEXSCOPE (K961536)Matrix Medica, Inc.1996-09-18
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL (K961239)Depuy, Inc.1996-09-17
PRESS-FIT POROUS SHELL (K961526)Encore Orthopedics, Inc.1996-09-17
OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS (K960647)Osteoimplant Technology, Inc.1996-09-17
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM (K961186)Depuy, Inc.1996-09-17
LATEX PATIENT EXAMINATION GLOVE (K960942)Siam Sempermed Corp., Ltd.1996-09-17
VERSALOK SCREW ASSEMBLY (PROPOSED NAME) (K961572)Wrightmedicaltechnologyinc1996-09-17
THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR (K960851)Pro-Tech Services, Inc.1996-09-17
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE (K961345)Applied Medical Technologies1996-09-17
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS (K960984)Biomet, Inc.1996-09-17
REFLECTION ACETABULAR REINFORCEMENT RINGS (K962541)Smith & Nephew Richards, Inc.1996-09-17
RHYDER DIAGNOSTIC CATHETER (K962307)Fidus Medical Technology Corp.1996-09-17
CROSS PIN (K961920)Medicinelodge, Inc.1996-09-17
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION (K962393)KARL STORZ Endoscopy-America, Inc.1996-09-17
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT (K952220)Meretek Diagnostics, Inc.1996-09-17
BRAUN HEMODIALYSIS CATHETER (K952660)B.Braun Medical, Inc.1996-09-17
RV PACING LEAD (K962467)Abbott Laboratories1996-09-17
BRAUN PERCUTANEOUS INTRODUCER SET (K961745)B.Braun Medical, Inc.1996-09-17
OLYMPUS MH-246R BALLOON SHEATH (K961048)Olympus America, Inc.1996-09-16
DRAGER MICRO VENT (K953238)Drager, Inc.1996-09-16
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 (K961941)Bio-Rad1996-09-16
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] (K962506)Gynecare Innovation Center1996-09-16
MEDLINE RADIOLOGY-DIAGNOSTIC KITS (K962826)Medline Industries, Inc.1996-09-16
DRUG CALIBRATOR II (K962817)Dade Intl., Inc.1996-09-16
IN THE EAR HEARING AID (K962388)Unique Hearing Technology, Inc.1996-09-16
CPR LIFE MASK COMPACT BARRIER (K954426)Carefree Trading, Inc.1996-09-16
BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 (K961928)Biomedix, Inc.1996-09-16
DANTEC DUET (K960503)Dantec Medical, Inc.1996-09-16
SELF RETAINING MALE EXTERNAL URINARY CATHETER (K962900)Hollister, Inc.1996-09-16
EG-3800T, VIDEO GASTROSCOPE (K962460)Pentax Precision Instrument Corp.1996-09-16
POLYPROPYLENE MESH (VARIOUS SIZES) (K962971)Davis & Geck, Inc.1996-09-16
HELPING HAND (K954427)Kinetic Rehabilitation Instruments, Inc.1996-09-16
ENDOSONICS AUTOMATIC PULL BACK DEVICE (K962293)Endosonics Corp.1996-09-16
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (K963275)Immuno Concepts, Inc.1996-09-13
CLEARVIEW C. DIFF A (K955067)Unipath , Ltd.1996-09-13
LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 (K961359)Bioprocessing, Inc.1996-09-13
STA-VWF CALIBRATOR KIT (K962671)American Bioproducts Co.1996-09-13
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Every clearance here is in the API, with alerts when new ones post.