Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ADI CATHETER WITH VALVE (K952924)Asia Dynamics, Inc.1995-08-18
TLC SURGICAL DRAPES (K951474)Tlc Tech Lab Clothes, Inc.1995-08-18
PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS (K936292)Howmedica Corp.1995-08-18
ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE (K945505)Ganz Industries Sdn. Bhd.1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 5410 (K951277)R & D Batteries, Inc.1995-08-18
TEC-2110 GREEN LASER MODEL MT-HNG (K950293)Medtec, Inc.1995-08-18
R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626 (K951274)R & D Batteries, Inc.1995-08-18
HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE (K934060)Howmedica Corp.1995-08-18
LINDNER/GOLOMB SP INTRODUCING SOUND (K953024)Cook Urological, Inc.1995-08-18
THE ASSISTANT (K952841)Apple Medical Corp.1995-08-18
RATESAVER PLUS (K952671)Entracare Corp.1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155 (K951284)R & D Batteries, Inc.1995-08-18
JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL (K951735)Joerns Healthcare, Inc.1995-08-18
ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE (K945504)Ganz Industries Sdn. Bhd.1995-08-18
MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM (K952828)Boston Scientific Corp1995-08-18
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION (K952240)Jeneric/Pentron, Inc.1995-08-18
R&D BATTERIES PART NOS. 5041 & 5655 (K951399)R & D Batteries, Inc.1995-08-18
RIZA-RIBE NEEDLE (K953441)R-Med, Inc.1995-08-18
DEPUY DURALOC 400 ACETABULAR CUP (K952740)Depuy, Inc.1995-08-18
ONE STEP URINE DRUG OF ABUSE COCAINE TEST (K951892)Tcpi, Inc.1995-08-17
CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER (K945693)Cardiovascular Dynamics, Inc.1995-08-17
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER (K950882)B.Braun Medical, Inc.1995-08-17
ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) (K952096)Tcpi, Inc.1995-08-17
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS (K952180)Beckman Instruments, Inc.1995-08-17
HOLTER PACERCORDER(R) (K950020)Del Mar Avionics1995-08-17
NELLCOR SYMPHONY N-3000 PULSE OXIMETER (K952316)Nellcor, Inc.1995-08-17
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM (K952741)Medical Diagnostic Technologies, Inc.1995-08-17
DIGITAL AVERAGING TONOMETER (K945972)Opti-Med Electronics1995-08-17
MEDI-TECH PLATFORM GUIDE CATHETER (K952345)Medi-Tech, Inc.1995-08-17
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER (K953481)American Hydro-Surgical Instruments, Inc.1995-08-16
CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER (K950684)Cynosure, Inc.1995-08-16
HERCULES RADIATION THERAPY COUCH (K950061)Precision Therapy Intl., Inc.1995-08-16
ULTRATHIN URETEROSCOPES (K951855)Olympus America, Inc.1995-08-16
BIPOLAR COAGULATING FORCEPS (K953509)KARL STORZ Endoscopy-America, Inc.1995-08-16
VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION (K952313)Varian Assoc., Inc.1995-08-16
CENTRALITE(R)-DLL SERIES (K950112)Diacor, Inc.1995-08-16
AOI LC-40 PHACOEMULSIFIER (K952331)American Optisurgical, Inc.1995-08-16
SALINE DRESSING (K952948)Busse Hospital Disposables, Inc.1995-08-16
CAPIOX SP PUMP HEAD (K943861)Terumo Corp.1995-08-15
HYS-SURGIFLATOR VP (K933847)W.O.M. World of Medicine GmbH1995-08-15
Z35 (K953051)Electone, Inc.1995-08-15
AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES (K950093)Smith & Nephew Richards, Inc.1995-08-15
PROSYS LEG BAG (K952208)Convatec, A Division of E.R. Squibb & Sons1995-08-15
NELLCOR N-20PA PORTABLE PULSE OXIMETER (K952222)Nellcor, Inc.1995-08-15
URIGLOW TRANSILLUMINATING URETERIC STENT MODEL (K943801)Rocket of London, Ltd.1995-08-15
SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) (K945429)Spacelabs Medical, Inc.1995-08-15
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION (K952396)Contour Fabricators of Florida, Inc.1995-08-15
ANESTHESIA/RESPIRATORY FACE MASK (K953107)Medical Marketing Concepts1995-08-15
PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (K932333)Gull Laboratories, Inc.1995-08-15
ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN (K953014)Diagnostic Products Corp.1995-08-15
WARM-SCALE (K952649)Olympic Medical Corp.1995-08-15
AM 260 K-AMP (K953052)Electone, Inc.1995-08-15
Z22 (K953048)Electone, Inc.1995-08-15
RUBELISA (RUBESTAT) (K950227)Bio-Whittaker, Inc., A Cambrex Co.1995-08-15
SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR (K950389)Sorba Medical Systems, Inc.1995-08-15
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) (K952363)Ela Medical, Inc.1995-08-15
AM 260 OHM (K953054)Electone, Inc.1995-08-15
PIPERACILIN TAZOBACTAM 4 UG (K953223)Ab Biodisk1995-08-15
RMI HEMOCONCENTRATOR (K951344)Research Medical, Inc.1995-08-15
CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM (K953261)Shared Systems, Inc.1995-08-15
REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION (K952395)Contour Fabricators of Florida, Inc.1995-08-15
Z24 (K953049)Electone, Inc.1995-08-15
ULTRACELL NEURO SPONGES (K950647)Ultracell Medical Technologies, Inc.1995-08-15
CENTURION UMBILICAL CATHETER (K942353)Tri-State Hospital Supply Corp.1995-08-15
AM 260 PP (K953053)Electone, Inc.1995-08-15
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN (K952360)Princeton BioMeditech Corp.1995-08-14
DYNA-LOK ANTERIOR PLATING SYSTEM (K936307)Danek Group, Inc.1995-08-14
ABBOTT TEST PACK STREP A TEST (K945571)Abbott Laboratories1995-08-14
COVERSAN, ISLESAN (K952547)Medical Device Development Co.1995-08-14
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES (K943778)Osteonics Corp.1995-08-14
ENDOCARE ELECTROSURGICAL HANDPIECE (K952698)Cytocare, Inc.1995-08-14
CUTINOVA CAVITY (K952526)Beiersdorf, Inc.1995-08-14
OSTEONICS PS HEMI-HIP STEM SERIES (K933882)Osteonics Corp.1995-08-14
BODYFLEX MASSAGER (K952041)Truro'S Ent.1995-08-14
CHAL-2500 (K946186)Hogan & Hartson1995-08-14
ELMED THERMO-FLUX (K952110)Elmed, Inc.1995-08-14
SERODIA ATG (K953066)Fujirebio America, Inc.1995-08-14
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES (K952789)Immunotech Corp.1995-08-14
SUNGLASSES (K941084)Blue Gem Sunglasses, Inc.1995-08-14
BX-400S (K942195)Bloomex International, Inc.1995-08-14
MING-YA OPTICAL INDUSTRIALCO., LTD. (K951801)Min-Ya Optical Industrial Co., Ltd.1995-08-14
S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II (K944321)Joint Medical Products Corp.1995-08-14
VISULINK 900 ARGON (K952894)Carl Zeiss, Inc.1995-08-14
BX-200 SC (K943185)Bloomex International, Inc.1995-08-14
INTEQ TFCC REPAIR SYSTEM (K941862)Linvatec Corp.1995-08-14
ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES (K952590)Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.1995-08-14
GLOVETEX (MULTIPLE) (K952197)Pt Mbf Buana Multicorpora1995-08-14
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM (K950074)Wrightmedicaltechnologyinc1995-08-11
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE (K952089)Rich-Mar Corp.1995-08-11
CREATINE KINASE REAGENT SYSTEM (K952745)Medical Diagnostic Technologies, Inc.1995-08-11
OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES (K951956)Osteonics Corp.1995-08-11
C-FLEX SEPTAL SPLINTS (K952226)Trebay Medical Corp.1995-08-11
FORMULATION HWS-64 EPA REG. NO. 47371-131 (K953011)Huntington Laboratories, Inc.1995-08-11
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 (K951584)Sigma Diagnostics, Inc.1995-08-11
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 (K952221)Boston Scientific Corp1995-08-11
BCW 600 POWER WHEELCHAIR (K945047)Wheelchairs of Kansas1995-08-11
9000 INFUSION PUMP (K944721)Graseby Medical , Ltd.1995-08-11
JEDMED LARYNGEAL SCOPE (K950925)Jedmed Instrument Co.1995-08-11
SMART PLUG (K950120)Hgm, Inc.1995-08-11
ECLIPSE 3200 (K953424)Cardiogenes1995-08-11
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Track 1995 automatically

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