Atlas FDA

1998

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

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RecordFirmDate
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL (K982772)Ge Medical Systems, Inc.1998-10-15
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K982872)Tg Medical Sdn. Bhd.1998-10-15
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY (K982680)Chiron Diagnostics Corp.1998-10-15
SMOKE-EVAC (K981888)Bio-Medical Devices, Inc.1998-10-15
FILM DIGITIZER MODEL 2905 (K982785)Array Corp.1998-10-15
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K981697)Cambridge Heart, Inc.1998-10-14
ECG ELECTRODES APRON (K982470)Tapuz Medical Technology , Ltd.1998-10-14
CARDIOPAL MODEL NUMBER PM20 (K981119)Medicomp, Inc.1998-10-14
COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER (K981744)W. Keith Thornton, D.D.S.1998-10-14
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO (K982487)Cardiopulmonary Technologies, Inc.1998-10-14
EXCEL AMBULATORY EEG (K982479)Excel Tech. , Ltd.1998-10-14
BARD HYDROPHILLIC COATED GUIDE WIRE (K974713)C.R. Bard, Inc.1998-10-14
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR (K982935)Beckman Coulter, Inc.1998-10-14
VGF-7 VASCULAR GRAFT FLOWMETER (K973198)Medicard , Ltd.1998-10-14
DRUG CALIBRATOR II (K982871)Dade Behring, Inc.1998-10-13
MINI-FIXATOR FOR COLLES FRACTURES (K982982)Biomet, Inc.1998-10-13
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK (K982688)Spectrum Designs, Inc.1998-10-13
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS (K981634)Biocircuits Corp.1998-10-13
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE (K983175)Ultrawin Sdn Bhd1998-10-13
PHILIPS EASYGUIDE (K980820)Philips Medical Systems, Inc.1998-10-13
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 (K974890)Acutek Adhesive Specialties, Inc.1998-10-13
BREATHE EASY, MODELS AD AND CD (K981841)Respiraid , Ltd.1998-10-13
INNOVASIVE TIBIAL FASTENER (K983056)Innovasive Devices, Inc.1998-10-13
TITANIUM HEMOSTATIC CLIP (K981645)Vitalitec Int'L., Inc.1998-10-13
COAGULATION FACTOR V DEFICIENT PLASMA (K981709)Dade Behring, Inc.1998-10-13
BTF THIN FILM WOUND DRESSING (K982939)Bioderm, Inc.1998-10-13
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 (K974892)Acutek Adhesive Specialties, Inc.1998-10-13
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY (K981597)Radionics, Inc.1998-10-09
MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (K982412)In-Line Diagnostics Corp.1998-10-09
CCA-220 (K982441)Benson Medical Instruments Co.1998-10-09
DISPOSABLE VINYL EXAM GLOVES, POWDERED (K982687)Shanghai Antares Industries, Inc.1998-10-09
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE (K981323)Novartis Nutrition Corp.1998-10-09
MEDRAD VISTRON CT INJECTOR SYSTEM (K982814)Medrad, Inc.1998-10-09
STERNOMEGA COMPOMER CEMENT (K982895)Sterngold/Implamed1998-10-09
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT (K981591)International Regulatory Consultants1998-10-09
MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K982691)Perusahaan Intan Emas Sdn. Bhd.1998-10-09
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC (K983162)Bio-Vascular, Inc.1998-10-09
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) (K982428)Innervision, Inc.1998-10-09
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC (K983492)Boehringer Mannheim Corp.1998-10-09
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS (K983327)Siemens Medical Solutions USA, Inc.1998-10-09
ONTRAK TESTCUP AND TESTSTIK CONTROLS (K983387)Roche Diagnostic Systems, Inc.1998-10-09
CENTAURI (K983211)Premier Laser Systems, Inc.1998-10-09
BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K982820)Barco NV Display Systems1998-10-08
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) (K982732)Synthes1998-10-08
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR (K982547)Steritec Products Mfg Co, Inc.1998-10-08
AIA-PACK TPOAB ASSAY (K981521)Tosoh Medics, Inc.1998-10-08
TEMPBOND CLEAR-2 (K982590)Sybron Dental Specialties, Inc.1998-10-08
ULTRACAM (K973410)W. Edward Johansen1998-10-08
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64 (K983222)Medical Advances, Inc.1998-10-08
AIA-PACK TGAB ASSAY (K981522)Tosoh Medics, Inc.1998-10-08
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM (K982484)Electro-Biology, Inc.1998-10-08
MILLENNIUM (K980585)Biolase Technology, Inc.1998-10-08
RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R (K982436)Woodside Biomedical, Inc.1998-10-08
ACCU-BITE HOME KIT DISCLUDER (K980953)Jerome M. Simon1998-10-07
MEDIVISION HYSTEROSCOPE (K982659)Medivision Scope Service Center, Inc.1998-10-07
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP (K982417)Innerdyne, Inc.1998-10-07
QUANTA LITE CHROMATIN ELISA (K982603)Inova Diagnostics, Inc.1998-10-07
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 (K974854)Morax1998-10-07
HEALTH CHECK URI-TEST PROTEIN IN URINE (K972960)Tcpi, Inc.1998-10-07
CODA MPX30 MOTION ANALYSIS SYSTEM (K982425)Pinsco Inc. Dba B & L Engineering1998-10-07
COBE VACUUM RELIEF CHECK VALVE (K982406)Cobe Cardiovascular, Inc.1998-10-07
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM (K974248)Air-Shields, Inc.1998-10-07
URISCREEN (K981084)Diatech Diagnostics,Inc.1998-10-07
ZYMED TELEMETRY SYSTEM (K980186)Agilent Technologies1998-10-07
ODC B2 BIPOLAR CUP (K982389)Ortho Development Corp.1998-10-07
HYDRAGEL 6 CSF KIT (K981048)Morax1998-10-07
MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (K982679)Spectral Diagnostics, Inc.1998-10-07
E.CAM EXTRA HIGH ENERGY COLLIMATOR (K982387)Siemens Medical Solutions USA, Inc.1998-10-06
MICROFUSE DUAL RATE INFUSER (K983321)Baxa Corp.1998-10-06
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA (K982245)Biosite Incorporated1998-10-06
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY (K983109)Medical Advances, Inc.1998-10-06
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (K982683)Telex Communications, Inc.1998-10-06
SPO2 FINGER PROBES (K973970)Medical Cables, Inc.1998-10-06
ULTRAPRO MODEL 98 (K982563)Ramsoft, Inc.1998-10-06
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO (K980906)Transonic Systems, Inc.1998-10-06
QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) (K981024)Marquette Medical Systems, Inc.1998-10-06
DELTON FS DIRECT DELIVERY SYSTEM (K982564)Dentsply Intl.1998-10-06
PHILIPS TOMOSCAN CS (K982631)Philips Medical Systems, Inc.1998-10-06
7250 ULTRASOUND IMAGING SYSTEM (K982444)Biosound Esaote, Inc.1998-10-06
BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE (K982690)Barco N.V.1998-10-06
DIGITAL RADIOGRAPHIC IMAGING SYSTEM (K982196)GE Medical Systems1998-10-06
BROWSER (EVENT SOFTWARE) MODEL # 4500E (K982550)Respironics, Inc.1998-10-05
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL (K982583)Shimadzu Corp.1998-10-05
DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM (K982585)DePuy Orthopaedics, Inc.1998-10-05
QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR (K982989)Sunrise Medical, Inc.1998-10-05
ULTIMA AIRFLOW SENSOR, 0510 (K981445)Braebon Medical Corp.1998-10-05
VMT SYSTEM (K971549)Target Health, Inc.1998-10-05
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 (K983121)Syntec Scientific Corp.1998-10-05
DEPUY C-STEM SYSTEM (K982918)DePuy Orthopaedics, Inc.1998-10-05
OTI MODULAR SHOULDER SYSTEM (K982886)Osteoimplant Technology, Inc.1998-10-05
ACTION STORM RANGER II, ACTION STORM POWER 9000 (K982064)Invacare Corp.1998-10-05
MOMENTUM NO. FS008 WHEELCHAIR (K982099)Sriram Enterprises D.B.A. Momentum Group1998-10-05
PANTHER WHEELCHAIR (K982849)Snug Seat, Inc.1998-10-05
OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE (K982734)The Olympus Optical Co.1998-10-05
TENOR SPINAL SYSTEM (K982490)Sofamor Danek USA,Inc.1998-10-05
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE (K982905)Karl Storz Endoscopy1998-10-05
RFG-3C PLUS (K982489)Radionics, Inc.1998-10-05
VAIL 1000 ENCLOSED BED (K982783)Vail Products, Inc.1998-10-05
MAGNATEK 40 (K982907)Magna Advanced Technologies, Inc.1998-10-02
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS (K982914)Aesculap, Inc.1998-10-02
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