Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB (K974318)Healthcare Service and Supply1998-02-13
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER (K974779)Abbott Laboratories1998-02-13
CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (K974336)J-Lloyd Medical, Inc.1998-02-13
MITEK KNOTLESS ANCHOR (K974345)Mitek Products1998-02-13
GALILEO DISPOSABLE HYSTEROSCOPES (K974297)Netoptix Corp.1998-02-13
NUMASTATION (K974444)Numa, Inc.1998-02-13
RTR-2000/RTR-4000 (K974307)Terarecon,Inc.1998-02-13
HYDROFERA FEMORAL WICK (K974316)Hydrofera, LLC1998-02-13
IISYS PACS SYSTEM (K980220)Sterling Diagnostic Imaging, Inc.1998-02-13
EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (K973395)Epitope, Inc.1998-02-13
STC CANNABINOIDS MICRO-PLATE EIA (K973750)OraSure Technologies, Inc.1998-02-13
EPI-UNION PLATING SYSTEM (K974289)Howmedica, Inc.1998-02-12
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST (K980205)San Diego Biotech1998-02-12
RANDOX MAGNESIUM (K974606)Randox Laboratories, Ltd.1998-02-12
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY (K980178)Bionostics, Inc.1998-02-12
OHMEDA-OHIO CARE PLUS INCUBATOR (K974349)Ohmeda Medical1998-02-12
ACS TOBRAMYCIN (K974029)Chiron Diagnostics Corp.1998-02-12
QUIKSTRIP ONE STEP BARBITURATE TEST (K974712)Syntron Bioresearch, Inc.1998-02-12
NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) (K974829)Kawasumi Laboratories Co., Ltd.1998-02-12
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL (K972512)Boston Scientific Scimed, Inc.1998-02-12
2700 SAMPLE MANAGER (K980180)Waters Corporation1998-02-12
VANISHPOINT SYRINGE (K980069)Retractable Technologies, Inc.1998-02-12
KROMATICA COLOR CHANGING ALGINATE (K974894)Matech, Inc.1998-02-12
BILIRUBIN-SL (TOTAL) ASSAY (K974874)Diagnostic Chemicals, Ltd. (Usa)1998-02-12
ABBOTT AXSYM SYSTEM (K974651)Abbott Laboratories1998-02-12
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 (K980316)Diagnostic Chemicals , Ltd.1998-02-12
FEMASSIST FLEXIBLE (K974645)Insight Medical Corp.1998-02-12
SNORE-EZZER (K974531)Snore - Ezzer1998-02-12
PASCO MIC AND MIC/ID PANELS (K974362)Pasco Laboratories, Inc.1998-02-12
0.2 U BACTERIAL FILTER (K974661)Sims Deltec, Inc.1998-02-11
VERSASTAT MULTIPOLAR SCISSORS AND CABLES (K974250)Pilling Weck, Inc.1998-02-11
ENSEMBLE CENTRAL STATION MONITOR (K970358)Mennen Medical, Inc.1998-02-11
PHASED ARRAY TRANSDUCER - - PVF -375DT (K972771)Toshiba America Medical Systems, In.C1998-02-11
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING (K971206)Howmedica Corp.1998-02-11
POWDERFREE LATEX EXAMINATION GLOVES (K974832)Servicom Services Sdn Bhd1998-02-11
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS (K972856)Rocket Medical Plc1998-02-11
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION (K973827)Kimberly-Clark Corp.1998-02-11
RENAMEL FLOWABLE COMPOSITE (K974494)Cosmedent, Inc.1998-02-10
FM RECEIVER - AUDITORY TRAINER (K974287)Phonic Ear, Inc.1998-02-10
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (K974295)Byron Medical1998-02-10
STERILE SALINE FOR CATHETER CARE (K974397)Baxter Healthcare Corp1998-02-10
CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) (K973225)Getinge/Castle, Inc.1998-02-10
AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM (K974239)Aktina Medical Physics Corp.1998-02-10
FRIALIT -2 SCREW (K974358)Friatec AG1998-02-10
CES MASSTRANSIT INFUSION CATHETER (K974222)Cordis Neurovascular, Inc.1998-02-10
ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE (K974484)Ximed/Prosure/Injectx1998-02-10
GSI 70 AUDIOPATH SCREENER (K974237)Grason-Stadler, Inc.1998-02-10
CANDELA GENTLELASE GL DERMATOLOGICAL LASER (K974381)Candela Corp.1998-02-10
UFI GEL C (K974772)Voco GmbH1998-02-10
MASKY (K973542)Pressing DI Monticelli Rag. Stefano1998-02-10
L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER (K974543)Luther Medical Products, Inc.1998-02-10
AMPLAID AM50 (K974235)Amplifon S.P.A.1998-02-10
LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT (K974323)Reddy Medtech Health Products , Ltd.1998-02-10
PALJET-B (K973663)Golden Gate Bio-Device1998-02-10
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM (K973867)Schwartz Electro-Optics, Inc.1998-02-10
40 CC GRANDE (K974247)Boston Scientific Corp1998-02-10
DENTAL D (K974622)Micro Dental Laboratories1998-02-10
LS-905 FIBERCHOICE ADAPTER SYSTEM (K974229)Laser Peripherals, LLC1998-02-10
O.B. APPLICATOR AND NON-APPLICATOR TAMPONS (K974629)Personal Products Co.1998-02-10
FRIALIT-2 CYLINDER (K974359)Friatec AG1998-02-10
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL (K974811)Boston Biomedica, Inc.1998-02-10
BALDUR NON-STERILE COTTON SPONGES (K974347)Baldur Systems Corp.1998-02-10
ALLERGEN IMMUNOCAP F256,F245,F207,F202 (K974580)Pharmacia & Upjohn Co.1998-02-09
POWDERED GREEN LATEX EXAMINATION GLOVES (K980039)Sri Johani Sdn. Bhd.1998-02-09
AIRIS II (K974212)Hitachi Medical Systems America, Inc.1998-02-09
PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES (K972478)Applied Medical Technologies1998-02-09
UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE (K973692)United Biotech, Inc.1998-02-09
IMMUNO CONCEPTS ANCA TEST SYSTEM (K974463)Immuno Concepts, Inc.1998-02-09
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) (K980037)Sri Johani Sdn. Bhd.1998-02-09
MODIFIED URETERAL INDWELLING CATHETER/STENT (K974541)Boston Scientific Corp1998-02-09
NTL-FLOW (K974483)Bisco, Inc.1998-02-09
POWDERFREE GREEN LATEX EXAMINATION GLOVES (K980038)Sri Johani Sdn. Bhd.1998-02-09
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST (K973350)Bio-Rad1998-02-09
LATEX CONDOMS (NATURAL COLOUR) (K974326)Reddy Medtech Health Products , Ltd.1998-02-09
POWDER-FREE NITRILE EXAMINATION GLOVES (K980150)Masju Sdn. Bhd.1998-02-09
COMPOSITE 168 RESTORATIVE SYSTEM (K973221)Dentsply Intl.1998-02-09
ALLERGAN IMMUNO CAP M4, M8, K70 (K974350)Pharmacia, Inc.1998-02-09
ULTRAGUIDE 1000 (K974432)Ultraguide , Ltd.1998-02-09
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (K980130)Radiometer America, Inc.1998-02-09
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT (K974324)Reddy Medtech Health Products , Ltd.1998-02-09
IMMUNO CONCEPTS ANCA TEST SYSTEMS (K974478)Immuno Concepts, Inc.1998-02-09
ENCORE MARK IV POWDER FREE SURGICAL GLOVES (K974783)Ansell Perry1998-02-09
ELASTYREN POWDER-FREE SURGICAL GLOVE (K971471)Eci Medical Technologies, Inc.1998-02-09
LATEX (POWDER FREE) LOW PROTEIN (K974853)P.T. Healthcare Glovindo1998-02-09
MANAN BILIARY DRAINAGE CATHETER (K980191)Medical Device Technologies, Inc.1998-02-09
MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES (K980211)Manan Medical Products, Inc.1998-02-06
CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER (K974301)Clk Intl., Inc.1998-02-06
PERIOPERATIVE DATA MANAGEMENT SYSTEM (K973949)Draeger Medical, Inc.1998-02-06
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM (K974520)Innovative Technologies (Us), Inc.1998-02-06
DIGENE DML 2000 MICROPLATE LUMINOMETER (K980120)Digene Corp.1998-02-06
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON (K974205)Convatec, A Division of E.R. Squibb & Sons1998-02-06
P.T. MACHINE (K974626)Goodman, Goodman & Goodman1998-02-06
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01) (K972740)Himex Production Corp.1998-02-06
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) (K972906)Medtronic Vascular1998-02-06
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM (K974331)Johnson & Johnson Professionals, Inc.1998-02-06
ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION (K974199)Marquette Medical Systems, Inc.1998-02-06
NOMOS SLIT COLLIMATOR (BEAK) (K974310)Nomos Corp.1998-02-06
PEBA ANCHOR/SUTURE COMBINATION (K972326)Orthopaedic Biosystems, Ltd.1998-02-06
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K974448)Cordis Corp.1998-02-06
PRECISION FLOW OSV II (K971799)Elekta Implants, SA1998-02-06
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