Atlas FDA

1998

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

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RecordFirmDate
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) (K982286)Besglove Medicare Sdn. Bhd.1998-08-11
PRO-FLEX DISPOSABLE PROPHY ANGLE (K981869)Professional Dental Mfg., Inc.1998-08-11
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE (K982274)Asia Pacific Latex Sdn Bhd1998-08-11
VICHY SHOWER (K980909)Bouvier Hydro, Inc.1998-08-11
MYELOTEC VIDEO GUIDED CATHETER (K980734)Myelotec, Inc.1998-08-11
SELECTOR DIAGNOSTIC CATHETER (K982077)Boston Scientific Scimed, Inc.1998-08-11
POWDER FREE SURGEONS GLOVE (K982586)Shiva Medicare , Ltd.1998-08-11
CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 (K982415)Cordis Webster, Inc.1998-08-10
HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS (K982313)Weck Closure Systems1998-08-10
IMMUNOWELL VCA IGM TEST (K973939)Genbio1998-08-10
PRINCE MEDICAL CEMENT PLUG (K981855)Prince Medical, Inc.1998-08-10
IMMUNOWELL EBV VCA IGG TEST (K973940)Genbio1998-08-10
IMMUNOWELL EBNA IGG TEST (K973941)Genbio1998-08-10
DIGITAL DOC (K981663)Digital Doc, LLC1998-08-10
ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) (K982201)Foremost Dental Mfg., Inc.1998-08-10
AECD ARRHYTHMIA DETECTION SOFTWARE (K982710)Cardiac Science, Inc.1998-08-10
ESTENIA (K982164)Kuraray America, Inc.1998-08-10
3M DENT II SYSTEM (K981647)3M Company1998-08-09
POS T-7000 (K981805)Pos Technologies, Inc.1998-08-07
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER (K982249)Idem (Int'L Dist. of Electronics For Medicine)1998-08-07
SLEEP MANAGEMENT SYSTEM (K981844)Rmp, Inc.1998-08-07
LIGHT SABER ASPIRATION NEEDLE (K982018)Minrad, Inc.1998-08-07
EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET (K980504)Schneider/Namic1998-08-07
STEALTHSTATION SYSTEM DIGITIZER CHANGE (K981686)Surgical Navigation Technologies, Inc.1998-08-07
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM (K982686)Sofamor Danek USA,Inc.1998-08-07
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (K980016)Genzyme Surgical Product (Genzyme Biosurgery)1998-08-07
INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD (K974588)Rimed , Ltd.1998-08-07
DIAGNOSTIC ULTRASOUND SYSTEM (K982498)Volumetrics Medical Imaging, Inc.1998-08-07
CAREDOP II (K982635)Nicolet Biomedical1998-08-07
SONOPSY LA SYSTEM (K980423)Neovision Corp.1998-08-07
CONTOR TABLE SURFACE (K973705)Hill-Rom, Inc.1998-08-07
RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 (K982130)New Deantronics, Ltd.1998-08-07
MEDTRONIC ZUMA GUIDING CATHETER (K981198)Medtronics Interventional Vascular1998-08-07
MICRO21 WITH URINE SEDIMENT ANALYSIS (K982301)Triangle Biomedical Sciences, Inc.1998-08-07
IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW (K981790)Elekta Oncology Systems, Ltd.1998-08-07
STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K981684)Surgical Navigation Technologies, Inc.1998-08-06
5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 (K974847)Arthrex, Inc.1998-08-06
X-AIR-CISER (K974849)Hougen Mfg., Inc.1998-08-06
BISSINGER CABLES, CAT. NO. 801000XX (K981919)Guenter Bissinger Medizintechnik GmbH1998-08-06
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM (K982011)DePuy Orthopaedics, Inc.1998-08-06
TOXOGEN (K981263)Instrumentation Laboratory CO1998-08-06
MINI-CISER (K974848)Hougen Mfg., Inc.1998-08-06
SILON SCAR STRIPS (K982036)Bio Med Sciences, Inc.1998-08-06
SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM (K974539)Resmed, Ltd.1998-08-06
GC IRRIGATOR (K980868)Gentle Colonics, Inc.1998-08-06
NIDEK LIGHTSCAN (K982295)Nidek, Inc.1998-08-06
DISETRONIC PENFINE INJECTION PEN NEEDLE (K982399)Disetronic Medical Systems1998-08-06
DBEST AMPHETAMINES TEST KIT (K981504)Ameritek, Inc.1998-08-06
B2-MICROGLOBULIN CONTROL SET SERUM (K982471)Boehringer Mannheim Corp.1998-08-06
GALILEO DISPOSABLE ENDOSCOPES (K981928)Galileo Electro-Optics Corp.1998-08-06
ASLAN SENSOR MODULAR INSTRUMENT (K982287)Aslan Medical Technologies, Ltd.1998-08-06
IMAGE VUE EEG (K980477)Sam Technology, Inc.1998-08-06
STABLEMAPR STEERABLE INTRACARDIAC CATHETERS (K981642)Medtronic Cardiorhythm1998-08-05
AUREX-3 (K981704)Adm Tronics Unltd, Inc.1998-08-05
STAT-SIMPLE PYLORI (K980782)Saliva Diagnostic Systems, Inc.1998-08-05
SMOKE EVACUATION ATTACHMENT 130XXX TBD (K982309)Conmedcorp1998-08-05
SILIMED TISSUE EXPANDER (K981852)Silimed, LLC1998-08-05
BARD QUANTUM SVR MODEL NUMBER H-6440VR (K981628)C.R. Bard, Inc.1998-08-05
SILIMED VAGINAL STENT (K974479)Silimed, LLC1998-08-05
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 (K971892)Biomedical Horizons, Inc.1998-08-05
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) (K982364)Radionics, Inc.1998-08-05
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT (K982236)Sigma Diagnostics, Inc.1998-08-05
SHELHIGH NO-REACT PNEUMOPLEDGETS (K981756)Shelhigh, Inc.1998-08-05
KELOCATE SHEETING (K982051)Allied Biomedical Corp.1998-08-05
UM-150A (K981908)Umeco Union Medical Engineering1998-08-05
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR (K980148)The Magstim Company , Ltd.1998-08-05
DADE TRU-LIQUID CARDIAC CONTROL (K982591)Dade Behring, Inc.1998-08-05
LIGHT SABER CORE TISSUE NEEDLE (K981796)Minrad, Inc.1998-08-05
RESPAIDE (K980052)Emergency Filtration Products, Inc.1998-08-05
CT 200 ELECTROCARDIOGRAPH (K961798)Macquarie Medical Systems1998-08-05
S2LO (K981640)Odyssey Optical Systems, LLC1998-08-05
NARKOMED 6000 MODEL NUMBER NM6000 (K980553)Draeger Medical, Inc.1998-08-04
ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR (K980197)Specialty Ultravision, Inc.1998-08-04
ANTAGON PORCELAIN (K982129)European Dental Imports, Inc.1998-08-04
V.F.I.-VISCOUS FLUID INFUSION TUBING SET (K981907)Peregrine Surgical , Ltd.1998-08-04
DIVAN ANESTHESIA VENTILATOR (K980208)Draeger Medical, Inc.1998-08-04
SYNTHES SPINE PEDIATRIC ROD SYSTEM (K980761)Synthes Spine1998-08-04
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (K974648)Sulzer Carbomedics, Inc.1998-08-04
ANGIOLAZ VES-1CAM (K981819)Angiolaz, Inc.1998-08-04
FLO-THRU (K981624)Bio-Vascular, Inc.1998-08-04
NASAL INTERFACE MODEL 7910 (K974453)Healthdyne Technologies, Inc.1998-08-04
POWDERED GREEN LATEX EXAMINATION GLOVES (K982284)Besglove Medicare Sdn. Bhd.1998-08-03
DIRECT LDL (K981303)Abbott Laboratories1998-08-03
ORTHOVU-1000 (K981898)Magnevu1998-08-03
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED (K982257)Taian Plastics Products (Jingxing) Co., Ltd.1998-08-03
POWDERFREE GREEN LATEX EXAMINATION GLOVES (K982285)Besglove Medicare Sdn. Bhd.1998-08-03
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES (K980106)Proma, Inc.1998-08-03
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X (K981776)Alexander Mfg. Co.1998-08-03
VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE (K982015)Taian Plastics Products (Jingxing) Co., Ltd.1998-08-03
DIRECT HDL (K981224)Abbott Laboratories1998-08-03
ACTIVE PSA ELISA (DSL-10-9700) (K973243)Diagnostic Systems Laboratories, Inc.1998-08-03
ACTIVE PSA IRMA (DSL-9700) (K973244)Diagnostic Systems Laboratories, Inc.1998-08-03
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) (K981181)Actimed Laboratories, Inc.1998-08-03
VITA TITANIUM PORCELAIN (K982664)Vident1998-08-02
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 (K981397)Toshiba America Medical Systems, In.C1998-07-31
PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) (K981627)Xintec Corporation1998-07-31
IMAGEQUEST (K974707)Visual Med, Inc.1998-07-31
PRODIGY 2 (K982148)Sybron Dental Specialties, Inc.1998-07-31
MANIFOLD WITH EXTENSION SET (K982368)Interpore Cross Intl.1998-07-31
OUTLOOK LARGE PHASED ARRAY NECK COIL (K981959)Philips Medical Systems (Cleveland), Inc.1998-07-31
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