Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
KOMET XK-95 PERFORATOR MOTOR (MI-102) (K991625)Komet Medical1999-07-30
HT, MODEL HT PB (K990142)Sulzer Oscor, Inc.1999-07-30
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS (K991708)Biomet, Inc.1999-07-30
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE (K991615)Maxxim Medical1999-07-30
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB (K983802)Lucas Medical, Inc.1999-07-30
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS (K991535)Hitachi Medical Corp. of America1999-07-30
BIORC ANCHOR (K990770)Linvatec Corp.1999-07-30
SCARAID SILICONE GEL SHEETING (K992146)Biodermis Corp.1999-07-30
OSTEONICS ACCP SYSTEM LINE EXTENSION (K992344)Howmedica Osteonics Corp.1999-07-30
SIDESTREAM NEBULIZER (K991725)Inspired Medical Products , Ltd.1999-07-30
PULSTAR (K992061)Lasermed, Inc.1999-07-30
AVE GL-1 GUIDING CATHETER (K984482)Arterial Vascular Engineering Massachusetts, Inc.1999-07-30
RABEA DEVICE, MODEL PXXXXXX (K990345)Signus Medizintechnik GmbH1999-07-30
QUICK-SERTER, MODEL 395 (K992300)Medtronic Minimed1999-07-29
BIOTHANE PATIENT RESTRAINT (K991591)Bioplastics1999-07-29
SD-100 SKYEAR THERMOMETER (K984506)Skylark Device Co., Ltd.1999-07-29
GORE-TEX DUALMESH BIOMATERIAL (K992189)W. L. Gore & Associates, Inc.1999-07-29
UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES (K991659)Medart Corp.1999-07-29
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE (K992177)Pt. Berlian Glovindo1999-07-29
PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED (K992100)Shanghai Palomar Mountain Industries, Inc.1999-07-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992206)Shanghai China Star Corp1999-07-29
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION (K991533)Peripheral Ave1999-07-29
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (K991512)Asahi Medical Co., Ltd.1999-07-29
BICORTICAL SCREW (K983120)Oraltronics Marketing-Und Vertriebs GmbH1999-07-29
MODIFICATION TO ZYMED HOLTER 2000 (K992197)Zymed Medical Instrumentation1999-07-28
VOYAGER QUAD CANNULA (K983270)Cardiothoracic Systems, Inc.1999-07-28
MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 (K991702)Becton Dickinson Vacutainer Systems1999-07-28
CRYOCHECK LA SURE, MODEL SUR25-10 (K990580)Precision Biologic1999-07-28
DADE BEHRING BFTII (K984501)Dade Behring, Inc.1999-07-28
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) (K984188)Chroma Vision Medical Systems, Inc.1999-07-28
PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 (K991945)Pharmacia & Upjohn Co.1999-07-28
SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 (K991503)United Pacific Co., Ltd.1999-07-28
PERFORMANCE KNEE SYSTEM (K992167)Biomet, Inc.1999-07-28
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM (K991497)Ics Medical Corp.1999-07-28
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 (K991517)Galil Medical , Ltd.1999-07-27
SWISS LITHOCLAST MULTIPURPOSE PROBE (K992251)Electro Medical Systems SA1999-07-27
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER (K984627)Arterial Vascular Engineering, Inc.1999-07-27
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) (K991668)Novartis Nutrition Corp.1999-07-26
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N (K990348)CooperSurgical, Inc.1999-07-26
LC PIT & FISSURE SEALANT (K991902)Bosworth Co.1999-07-26
FASTRAY LC (K991631)Harry J. Bosworth Co.1999-07-26
ENHANCE-S PLUS (K991322)Conception Technology, Inc.1999-07-26
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) (K992020)Brightsway Holdings Sdn Bhd1999-07-26
SULLIVAN AUTOSET NASAL CPAP SYSTEM (K984428)Resmed, Ltd.1999-07-26
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST (K990349)CooperSurgical, Inc.1999-07-26
WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 (K990350)CooperSurgical, Inc.1999-07-26
GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE (K992244)Greiner Meditech, Inc.1999-07-26
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE (K992216)Integra Lifesciences Corp.1999-07-26
PENTAMIX 2 (K991913)Espe Dental AG1999-07-26
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) (K991951)Safeskin Corp.1999-07-26
LUER ACCESS INJECTION SITE (K984060)Baxter Healthcare Corp1999-07-26
VANTAGE 2.5 (K991607)Adac Laboratories1999-07-26
CARESIDE PT (K991065)Careside, Inc.1999-07-26
REDI-TEST COCAINE (K991110)Redwood Biotech, Inc.1999-07-26
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) (K992021)Brightsway Holdings Sdn Bhd1999-07-23
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) (K991586)Osteotech, Inc.1999-07-23
DOCUMENT THYROID CAL*VER (K992034)Casco-Nerl Diagnostics Corporation (Maine)1999-07-23
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K992205)Shanghai China Star Corp1999-07-23
PVS 1400 GUIDEWIRE (K990823)Precision Vascular Systems, Inc.1999-07-23
LAP-WAVE 3000 (P07) (K990732)W.O.M. World of Medicine GmbH1999-07-23
FOUNTAIN Infusion Catheter and Occluding Guide Wire (K992231)Merit Medical Systems, Inc.1999-07-23
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) (K990618)Ventana Medical Systems, Inc.1999-07-23
OSTEONICS HA-COATED DEVICES (K980070)Osteonics Corp.1999-07-23
BIOSACA SYSTEM, MODEL 800 (K991446)Biosys AB (Publ)1999-07-23
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (K992041)Immuno Concepts, Inc.1999-07-23
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) (K990579)Precision Biologic1999-07-23
COBAS INTEGRA ACETAMINOPHEN (K991598)Roche Diagnostics Corp.1999-07-22
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION (K990476)Hewlett-Packard GmbH1999-07-22
COBAS INTEGRA AMIKACIN MAB (K991597)Roche Diagnostics Corp.1999-07-22
TRANSFX MULTI PIN CLAMP (K991723)Immedica, Inc.1999-07-22
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991817)Bayer Corp.1999-07-22
INSULSCAN INSULATION TESTING SYSTEM (K991424)Medicor Corp.1999-07-22
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM (K992207)Syntron Bioresearch, Inc.1999-07-22
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 (K991741)Biocheck, Inc.1999-07-22
SNORE-AID PLUS (K991449)Dental Imagineers, LLC1999-07-22
REDI-TEST METHAMPHETAMINE (K991504)Redwood Biotech, Inc.1999-07-22
SCIMED ANGIOGRAPHIC CATHETERS (K992142)Scimed1999-07-21
PRO-GLASS (K991844)Cad Cam Ventures1999-07-21
FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800 (K992328)Meditec Co., Ltd.1999-07-21
ANSELL CONDOMS (K984392)Ansell, Inc.1999-07-21
EMS SWISS ORTHOCLAST (K991588)(Ems Sa) Electro Medical Systems1999-07-21
MEDRAD VISTRON CT INJECTOR SYSTEM (K991557)Medrad, Inc.1999-07-21
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF (K991525)Deroyal Industries, Inc.1999-07-20
SYNOCTA PROSTHETICS (K990342)Straumann USA1999-07-20
ELEKTA STEREOTACTIC GUIDE (K991636)Elekta Instrument AB1999-07-20
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM (K984180)Zeus Scientific, Inc.1999-07-20
SYNTHES CRANIAL FLAP TUBE CLAMP (K992000)Synthes (Usa)1999-07-20
CICACARE MANAGEMENT FOR SCARS (K991957)Smith & Nephew, Inc.1999-07-20
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING (K991609)Dermaphylyx, Inc.1999-07-20
Q-LITE 75 LIGHT CURE UNIT (K991865)Rolence Enterprise Co. , Ltd.1999-07-20
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (K991608)Dermaphylyx, Inc.1999-07-20
OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM (K990712)Howmedica Osteonics Corp.1999-07-20
AWARE PAD (K991469)Aac Consulting Group, Inc.1999-07-20
CHROMOPHARE D 530 LDR SURGICAL LIGHT (K990656)Berchtold Holding GmbH1999-07-20
SYNTHES CRANIAL FLAP TWIST CLAMP (K991860)Synthes (Usa)1999-07-20
ENDOSCOPIC CAMERA (K991416)Genzyme Surgical Product (Genzyme Biosurgery)1999-07-20
DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 (K991464)Fisma, Inc.1999-07-20
MR SPECTROSCOPY PACKAGE (K991568)Philips Medical Systems (Cleveland), Inc.1999-07-19
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO (K991700)Swemed Lab International AB1999-07-19
MICROTOOLS (K991104)Conception Technology, Inc.1999-07-19
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