Atlas FDA

1998

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

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RecordFirmDate
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 (K981713)Smith & Nephew, Inc.1998-07-31
MX MEVATRON (K982513)Siemens Medical Solutions USA, Inc.1998-07-31
MTA MATERIAL II (K981620)Dentsply Intl.1998-07-31
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE (K981889)Worldwide Medical Technologies, LLC1998-07-31
EPIDURAL NEEDLE (K980536)Manan Medical Products, Inc.1998-07-31
GENESIS IMRT LINEAR ACCELERATOR (K982502)Siemens Medical Solutions USA, Inc.1998-07-31
IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS (K982302)Implex Corp.1998-07-31
CALM (K980719)Lms Medical Systems , Ltd.1998-07-31
POLYCARBOXYLATE CEMENT (K980990)Medental Intl.1998-07-31
ULTRAPAK E (K981596)Ultradent Products, Inc.1998-07-31
IMAGYN 125 I SEED, MODEL IS 125 (K982421)International Isotopes, Inc.1998-07-31
UIBC (K982041)Abbott Laboratories1998-07-30
HEPTRAC ELECTRONIC QUALITY CONTROL (K981815)Medtronic Blood Management1998-07-30
SNAP-N-PEEL INTRODUCERS (K981611)Circon Corp.1998-07-30
DIPSTREAK (K974428)Novamed , Ltd.1998-07-30
DURA-GUARD - DURAL REPAIR PATCH (K982282)Bio-Vascular, Inc.1998-07-30
DIRECT HDL-CHOLESTROL LIQUID (K982341)Randox Laboratories, Ltd.1998-07-30
PYLORIPROBE (K981396)Amdl, Inc.1998-07-30
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM (K980821)Zeus Scientific, Inc.1998-07-30
SENSOREX BLOOD GLUCOSE MONITORING SYSTEM (K980573)Chronimed, Inc.1998-07-30
ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES (K981589)Conway Stuart Medical, Inc.1998-07-30
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT (K981562)Sulzer Calcitek, Inc.1998-07-30
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) (K972913)Pacific Materials and Interfaces1998-07-30
PASCO MIC AND MIC/ID PANELS (K982235)Pasco Laboratories, Inc.1998-07-30
PROFILE-II MODEL 600582 (K982211)Medtox Diagnostics, Inc.1998-07-29
LUNA (K982351)Stellate Systems1998-07-29
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM (K982222)Synthes (Usa)1998-07-29
QUANTA LITE TPO ELISA (K981857)Inova Diagnostics, Inc.1998-07-29
OLYMPUS NEURO ENDOSCOPE (K971340)Olympus Optical, Co.1998-07-29
MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES (K980389)Ceram Optec, Inc.1998-07-29
MICRO II MICROCURRENT TENS (K973978)Apex Medical Corp.1998-07-29
DISTAL RADIUS FRACTURE FIXATION PLATE (K981715)Avanta Orthopaedics, Inc.1998-07-29
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) (K981856)Greatbatch Scientific1998-07-29
DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE (K981775)Depuy Ace Medical Co.1998-07-29
MULTI-STIM TENS, AP-101081T (K973979)Apex Medical Corp.1998-07-29
QUIDEL CH50 EQ EIA (K974111)Quidel Corp.1998-07-29
HICHEM CALCIUM REAGENT KIT (K981794)Hichem Diagnostics1998-07-29
ACU-STIM TENS, AP-101082T (K973980)Apex Medical Corp.1998-07-29
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO (K980962)Brennen Medical, Inc.1998-07-29
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (K981821)Angiolaz, Inc.1998-07-29
SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288)Spine-Tech, Inc.1998-07-29
PASCO MIC AND MIC/ID PANELS/ CEFDINIR (K982156)Pasco Laboratories, Inc.1998-07-29
DOC VENTRAL CERVICAL STABILIZATION SYSTEM (K982443)Depuy Motech Acromed1998-07-29
MULTAPORT CANNULA REDUCER AND ACCESSORIES (K981941)Dexide, Inc.1998-07-29
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) (K981675)Besglove Medicare Sdn. Bhd.1998-07-28
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER (K981601)Sorin Group Italia S.R.L.1998-07-28
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y (K981683)Venusa , Ltd.1998-07-28
C0-AXIAL INTRODUCER NEEDLE (K981721)Inrad1998-07-28
MODIFICATION TO THE OXYCONALPHA (K980094)Erich Jaeger B.V.1998-07-28
CT 100 ELECTROCARDIOGRAPH (K981951)Macquarie Medical Systems1998-07-28
POWDERED GREEN NITRILE EXAMINATION GLOVES (K981674)Besglove Medicare Sdn. Bhd.1998-07-28
INFLUENCE CLIP SYSTEM (K981631)Influence, Inc.1998-07-28
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM (K981827)Angiolaz, Inc.1998-07-28
MYO-TRAIN V (5) (K980158)Sterne Equipment Co., Ltd.1998-07-28
LIQUID A (K981618)Harry J. Bosworth Co.1998-07-28
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (K981673)Besglove Medicare Sdn. Bhd.1998-07-28
UREA (K981918)Abbott Laboratories1998-07-28
EUP-OL334 LAPARASCOPICPROBE (K981434)Hitachi Medical Corp. of America1998-07-27
PHOTON RADIOSURGERY SYSTEM PRS400 (K980526)Pec Photoelectron Corp.1998-07-27
MCS-MEDICATED CANAL SEALER (K973636)Dr. Howard Martin, P.A.1998-07-27
MPS RESERVOIR BAG (K982048)Medical Product Specialists1998-07-27
MENISCAL REPAIR DEVICE (K981692)Linvatec Corp.1998-07-27
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 (K974445)3M Healthcare1998-07-26
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM (K982232)Irvine Biomedical, Inc.1998-07-25
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K981774)Pwa Industries Sdn. Bhd.1998-07-24
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM (K981736)Organon Teknika Corp.1998-07-24
BALADI INVERTER WITH COAXIAL AORTIC PUNCH (K980128)Cardio Medical Solutions, Inc.1998-07-24
CARRIAZO BARRAQUER MICROKERATOME (K981741)Moria, Inc.1998-07-24
RESOR-PIN RESORBABLE MEMBRANE PIN (K972817)Geistlich-Pharma1998-07-24
CARESIDE ANALYZER (K982118)Exigent Diagnostics, Inc.1998-07-24
OTO WIZZARD (K981511)Medrx, Inc.1998-07-24
MOBETRON (K981112)Intraop Medical, Inc.1998-07-24
XENON LIGHT SOURCE MODEL LS6000 (K981804)Contec Medical Vision, Ltd.1998-07-24
LIQUID ENZYME ID 90133 (K981561)Alcon Laboratories1998-07-24
SENSITEX EXAMINATION GLOVE (K981963)Oak Carolina, Inc.1998-07-24
ALTRA NOVA 200 HEMODIALYZER (K970681)Althin Medical AB an Affiliate of Baxter Intl1998-07-23
DENTAL PORCELAIN-VARIOUS (K981708)Excel Porcelain Products1998-07-23
TSX PRM PULMONARY RESUSCITATION MONITOR (K973347)Spiracle Technology1998-07-23
ALTRA FLUX 200 HEMODIALYZER (K970679)Althin Medical AB an Affiliate of Baxter Intl1998-07-23
ML MICROKERATOME (K981071)Med-Logics, Inc.1998-07-23
TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 (K981078)Transtracheal Systems1998-07-23
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA (K982269)Allegiance Healthcare Corp.1998-07-23
VIPERCAM (K981534)Integra Medical1998-07-23
UBI MAGIWEL MARIJUANA METABOLITES (K973154)United Biotech, Inc.1998-07-22
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR (K981978)Pointe Scientific, Inc.,1998-07-22
VERABOND 2 (K982094)Aalba Dent, Inc.1998-07-22
TIBC (K981654)Abbott Laboratories1998-07-22
DBIL (K981943)Abbott Laboratories1998-07-22
TRUBYTE DENTURE BOND DENTURE BONDING AGENT (K982007)Dentsply Intl.1998-07-22
WIELISA ANCA SCREENING KIT TEST SYSTEM (K981748)Wieslab AB1998-07-22
VCA IGM ELISA TEST SYSTEM (K980596)Clark Laboratories, Inc.1998-07-22
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (K980635)Dako Corp.1998-07-22
DADE INNOVIN (K974343)Dade Intl., Inc.1998-07-22
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) (K982277)Nova Biomedical Corp.1998-07-22
CREA (K981799)Abbott Laboratories1998-07-22
AMM (K981920)Abbott Laboratories1998-07-22
SPIROBANK PORTABLE PC BASED SPIROMETER (K973456)Futuremed America, Inc.1998-07-22
CHEM-CHEX STAT (NEW) (K982290)Streck Laboratories, Inc.1998-07-22
SANDS SERIES III HYPERBARIC CHAMBER (K972908)Sands Hyperbarics1998-07-22
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP (K981444)Princeton BioMeditech Corp.1998-07-22
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