Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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RecordFirmDate
RAPIDONE- BENZODIAZEPINE TEST (K992720)American Bio Medica Corp.2000-04-03
RANDOX FERRITIN (K000662)Randox Laboratories, Ltd.2000-04-03
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A (K000459)Dade Behring, Inc.2000-04-03
OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 (K000797)Orthopaedic Biosystems, Ltd.2000-04-03
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I (K993208)OraSure Technologies, Inc.2000-04-03
WEHRS INCUS-STAPES (K000858)Gyrus Ent LLC2000-04-03
RAPIDONE- BARBITURATE TEST (K992451)American Bio Medica Corp.2000-04-03
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I (K992918)OraSure Technologies, Inc.2000-04-03
INSUFFLATION NEEDLE, MODEL R65-933 (K000027)A & A Medical, Inc.2000-04-03
WAKO L-TYPE UN TEST (K993925)Wako Chemicals USA, Inc.2000-04-03
HYDROCISION DEBDRIDEMENT SYSTEM (K991383)Hydrocision, Inc.2000-03-31
S57D DIGITAL OPERATING ROOM CAMERA (K000422)Sopro2000-03-31
RANDOX ALBUMIN (K000483)Randox Laboratories, Ltd.2000-03-31
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K993512)Datex-Ohmeda, Inc.2000-03-31
BITX PROBES (K993412)Everest Medical Corp.2000-03-31
UNIPOLAR NEEDLES (K000722)Pajunk GmbH2000-03-31
HARDYDISK, CEFOXITIN, 30MCG (K000305)Hardy Diagnostics2000-03-31
CORTEK LAPAROSCOPES (K000202)Cortek Endoscopy, Inc.2000-03-31
ENVOY AND VISTA BRITE TIP (K000715)Cordis Corp.2000-03-31
DIMEX 2 (K000454)Planmeca Oy2000-03-31
ISOSEED PD-103 (K993552)Bebig Isotopentechnik GmbH2000-03-31
S52D DIGITAL VIDEO LAPAROSCOPE (K000423)Sopro2000-03-31
RTLX (K992392)Infimed, Inc.2000-03-31
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER (K000731)Talia Technology , Ltd.2000-03-31
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER (K000026)Apple Medical Corp.2000-03-31
S51D DIGITAL ENDOSCOPY CAMERA (K000424)Sopro2000-03-31
LEVEEN NEEDLE ELECTRODE (K000032)Radiotherapeutics Corp.2000-03-30
DIMENSION GARANT L, DIMENSION GARANT L QUICK (K000588)Espe Dental AG2000-03-30
MICRINS MICROSURGICAL SUTURE (K993970)Micrins Surgical, Inc.2000-03-30
MONOFILAMENT BIOSYN SUTURE (K000037)United States Surgical, A Division of Tyco Healthc2000-03-30
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) (K000046)Richard Wolf Medical Instruments Corp.2000-03-30
SMITH & NEPHEW SUTURELOK, MODEL 7207321 (K000717)Smith & Nephew, Inc.2000-03-30
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS (K000697)Allegiance Healthcare Corp.2000-03-30
COLORADO II SPINAL SYSTEM (K984360)Sofamor Danek USA,Inc.2000-03-30
BRANEMARK NOVUM (K000018)Nobel Biocare Uas, Inc.2000-03-30
VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER (K000369)Medpro Technologies, Inc.2000-03-30
DIMENSION PENTA H, DIMENSION PENTA H QUICK (K000591)Espe Dental AG2000-03-30
PACIFIC SURGICAL PATTIES (K993019)V. Mueller Neuro/Spine2000-03-30
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT (K993041)The Olympus Optical Co.2000-03-30
MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED (K992215)Envitec-Wismar GmbH2000-03-29
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING (K000671)Sgmp Co., Ltd.2000-03-29
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT (K000659)Merit Medical Systems, Inc.2000-03-29
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992554)Shijiazhuang Great Vision Plastic Products Co., LT2000-03-29
SINGLE SIZE TENDON SPACER (K000019)Medist International2000-03-29
ZUMA GUIDE CATHETERS (K000677)Medtronic Vascular2000-03-29
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY (K000293)Barco N.V.2000-03-29
SPIRO PRO (K000648)Erich Jaeger GmbH2000-03-29
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 (K000154)E. Benson Hood Lab, Inc.2000-03-29
EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER (K994026)Hitachi Medical Corp. of America2000-03-29
HARDYDISK, TETRACYCLINE 30MCG (K000304)Hardy Diagnostics2000-03-29
SYNTHES ANTERIOR CSLP SYSTEM (K000742)Synthes Spine2000-03-29
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES (K993201)Pamitex Industries Sdn Bhd2000-03-29
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY (K000292)Barco N.V.2000-03-29
AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 (K994423)Vsm Medtech , Ltd.2000-03-28
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (K000495)Ballard Medical Products2000-03-28
WESCO BLANKET (K981093)Wesco, Inc.2000-03-28
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER (K993199)Ferraris Medical, Inc.2000-03-28
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM (K994430)General Electric Medical Systems Information Techn2000-03-28
GAS FILTER (K993060)Olson Medical Sales, Inc.2000-03-28
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 (K000013)Acist Medical Systems2000-03-28
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (K994278)Beckman Coulter, Inc.2000-03-28
UCLA/UNIVERSAL ABUTMENT (K993129)Diamodent2000-03-28
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 (K000660)Medical Data Electronics2000-03-28
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (K994194)Cardiovascular Diagnostics, Inc.2000-03-28
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0 (K992303)Nucletron Corp.2000-03-27
MFCD 120 (K000294)Barco N.V.2000-03-27
MLC FIT (K991133)Impac Medical Systems, Inc.2000-03-27
RANDOX COMPLEMENT C3 (K000469)Randox Laboratories, Ltd.2000-03-27
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 (K000060)Senorx, Inc.2000-03-27
VENTRICULAR ANALYSIS TOOLKIT OPTION (K000315)GE Medical Systems2000-03-27
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES (K983214)Rita Medical Systems2000-03-27
RANDOX COMPLEMENT C4 (K000468)Randox Laboratories, Ltd.2000-03-27
MFCD 118 (K000291)Barco N.V.2000-03-27
NOVA CORDLESS CURING LIGHT (K000393)Nova/Da Vinci Systems, Inc.2000-03-27
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED (K994389)Cobe Cardiovascular, Inc.2000-03-27
RETIC CHEX LINEARITY (K000115)Streck Laboratories, Inc.2000-03-27
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (K000600)Syva Co., Dade Behring, Inc.2000-03-27
MCA-601, C-ARM MOBILE (K993896)Medison Radiology Systems, Inc.2000-03-27
ULTICARE DISPOSABLE SYRINGE (K994230)Ultimed, Inc.2000-03-24
THROMBOSTRATE CONTROL PLASMAS (K000679)Pacific Hemostasis2000-03-24
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION (K000821)Abbott Laboratories2000-03-24
AESCULAP BONE WAX (K000021)Aesculap, Inc.2000-03-24
RUSCH MANUAL RESUSCITATOR BAG (K993194)Rusch, Inc.2000-03-24
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN (K000169)Dentsply Intl.2000-03-24
5F GUIDING CATHETER (K000598)Guidant Corp.2000-03-24
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM (K994370)Ortho Development Corp.2000-03-24
FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA (K994376)Friadent GmbH2000-03-24
HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) (K994373)Atl Ultrasound, Inc.2000-03-24
HARDY DISK, PENICILLIN, 10 UNITS (K000302)Hardy Diagnostics2000-03-24
BELLEGLASS HP TRANSLUCENT DENTIN (K000436)Sybron Dental Specialties, Inc.2000-03-24
TFX MEDICAL INTRODUCER ASSEMBLY (K993191)Tfx Medical, Inc.2000-03-24
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER (K993292)Boston Scientific, Target2000-03-23
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES (K994431)Shimadzu Medical Systems2000-03-23
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY (K000564)Cordis Corp.2000-03-23
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM (K983826)Unimachs Corp.2000-03-23
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP (K992174)Pilling Weck Surgical2000-03-23
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER (K993303)Boston Scientific Corp2000-03-23
EP MEDSYSTEMS, EP-WORKMATE (K994011)Ep Medsystems, Inc.2000-03-23
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 (K000616)Bionx Implants, Ltd.2000-03-23
NARKOMED 6000 (K993826)Draeger Medical, Inc.2000-03-23
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Every clearance here is in the API, with alerts when new ones post.