Atlas FDA

2005

3,156 FDA 510(k) clearances · Clearance year

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RecordFirmDate
FRESENIUS LIBERTY CYCLER (K043363)Fresenius Medical Care North America2005-03-31
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY (K050047)Cutera, Inc.2005-03-31
GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR (K043352)Gocanning Technology , Ltd.2005-03-31
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM (K050639)Lumenis, Inc.2005-03-31
COOK IRELAND SONNET POLYPECTOMY SNARE (K050294)Cook Ireland, Ltd.2005-03-31
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM (K050730)Ultradent Products, Inc.2005-03-31
FLEXIBLE SPINAL NEEDLE (K043467)Epimed International, Inc.2005-03-31
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 (K050577)Boston Scientific Corp2005-03-30
MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR (K050040)Mars Medical Products2005-03-30
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN (K050467)Shen Wei (Usa), Inc.2005-03-30
MOONCUP, STYLE A & B (K040335)Mooncup, LLC2005-03-30
MINIMASTER ULTRASONIC SCALER (K050710)E.M.S Electro Medical Systems S.A2005-03-30
SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS (K050670)Tms Telemedizinische Systeme GmbH2005-03-30
HL168JP (K050249)Health & Life Co., Ltd.2005-03-30
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP (K043204)Sgarlato Laboratories, Inc.2005-03-30
HEMOSIL SILICA CLOTTING TIME (K050221)Instrumentation Laboratory CO2005-03-30
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) (K050217)Biosense Webster, Inc.2005-03-30
MODIFICATION TO:ZILVER 518 BILIARY STENT (K050698)Cook, Inc.2005-03-30
NOVOFINE AUTOCOVER 30G X 8MM (K050106)Novo Nordisk, Inc.2005-03-30
PREGNANCY-SKREEN (K050328)Biochemical Diagnostic, Inc.2005-03-29
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (K050043)Dade Behring, Inc.2005-03-29
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C (K043600)Medtronic Minimed2005-03-29
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES (K050455)Zibo Blue Intco Plastic & Rubber Products Co., Ltd.2005-03-29
OSSAPLAST ORTHO (K050416)Ossacur AG2005-03-29
EKOS PERIPHERAL INFUSION SYSTEM (K050563)Ekos Corp.2005-03-29
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT (K050539)Howmedica Osteonics Corp.2005-03-29
CIE FOLDAWAY WHEELCHAIR (K050345)Carlsbad International Export, Inc.2005-03-29
R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE (K050667)R2 Technology, Inc.2005-03-29
IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 (K050341)Tactile Technologies, Ltd.2005-03-29
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM (K042384)Cyberkinetics, Inc. (Cki)2005-03-29
FRESHLOOK ONE-DAY COLOR CONTACT LENS (K050213)Ciba Vision Corporation2005-03-28
PACHPEN PACHYMETER, MODEL 24-5100 (K050552)Accutome, Inc.2005-03-28
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D (K050623)Volk Optical, Inc.2005-03-28
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM (K042626)Cyberkinetics, Inc.2005-03-28
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT (K043556)Beckman Coulter, Inc.2005-03-28
MAESTRO CARPAL HEMIARTHROPLASTY (K050028)Biomet Manufacturing, Inc.2005-03-25
BIOLOX DELTA CERAMIC HEADS (K042091)Biomet, Inc.2005-03-25
VISITRAK, VERSION 1, RELEASE 1 (K050372)Math Resolutions, LLC2005-03-25
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM (K050626)Datex-Ohmeda, Inc.2005-03-25
MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR (K050039)Mars Medical Products2005-03-25
REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K043392)Alliance Medical Corp.2005-03-25
K-LASER, MODELS 3,4,4D,6D (K050070)Eltech S.R.L2005-03-25
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 (K050309)Viasys Medsystems2005-03-25
MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS (K050514)Mri Devices Corporation2005-03-25
CORDLESS COIL (K050476)Siemens Medical Solution, Inc. USA2005-03-25
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I (K050509)Cti Pet Systems, Inc.2005-03-25
GE DATEX-OHMEDA ENGSTROM CARESTATION (K050597)Datex-Ohmeda, Inc.2005-03-25
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 (K041881)Hypoguard USA, Inc.2005-03-25
BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (K050497)Linvatec Corp.2005-03-25
APOLLO (K050190)Villa Sistemi Medicali S.P.A.2005-03-25
MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR (K050697)Nihon Seimitsu Sokki Co., Ltd.2005-03-25
SE INFUSION SYSTEM WITH MMS (K043590)Cardinal Health, Alaris Products2005-03-25
EPI-K (K043183)Moria SA2005-03-25
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES (K050295)Helio Medical Supplies, Inc.2005-03-25
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS (K050504)Maine Standards Co.2005-03-25
DYNAGRAFT II (K040419)Isotis Orthobiologics, Inc.2005-03-25
ALLIGATOR RETRIEVAL DEVICE (ARD) (K043580)Chestnut Medical Technologies, Inc.2005-03-24
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS (K050272)Cryomedical Instruments, Ltd.2005-03-24
ADHESIVE 1 (K050331)Southern Dental Industries, Inc.2005-03-24
4D INTEGRATED TREATMENT CONSOLE (K050479)Varian Medical Systems2005-03-24
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 (K043454)Medicomp, Inc.2005-03-24
BIOSYAG 50 MED (K043521)Bios S.R.L.2005-03-24
MRIDIUM 3850 MRI PUMP SYSTEM (K050301)Iradimed Corporation2005-03-24
CD HORIZON SPINAL SYSTEM (K050439)Medtronic Sofamor Danek, Inc.2005-03-24
SYNTHES VECTRA SYSTEM (K050451)Synthes Spine Co.Lp2005-03-24
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 (K041715)Nucletron Corp.2005-03-24
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II (K043613)Quantel Medical2005-03-24
HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE (K050163)Henke Sass Wolf of America, Inc.2005-03-24
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL (K050536)Bio-Rad2005-03-24
MEGA POWER ELECTROSURGICAL GENERATOR (K050579)Megadyne Medical Products, Inc.2005-03-24
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 (K050440)Ceremed , Inc.2005-03-24
ENCORE REVERSE SHOULDER PROSTHESIS (K041066)Encore Medical L.P.2005-03-24
OXYBAND WOUND DRESSING (K043063)Oxyband Technologies, Inc.2005-03-24
14F DUAL FLOATING DIALYSIS CATHETER/TRAY (K042672)Cardio Med Supplies, Inc.2005-03-23
REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS (K043393)Alliance Medical Corp.2005-03-23
TRIACTIV SYSTEM (K042040)Kensey Nash Corp.2005-03-23
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS (K050591)Raven Biological Laboratories, Inc.2005-03-23
TITAN DENTAL IMPLANT ATTACHMENT (K042715)Titan Implants, Inc.2005-03-23
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN (K042058)Clement Clarke Intl., Ltd.2005-03-23
IQ 200 URINE ANALYZER BODY FLUIDS MODULE (K050235)Iris International, Inc.2005-03-23
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM (K043344)Dialysis Services, Inc.2005-03-23
MILLENNIUM MULTI-LEAF COLLIMATOR (K050442)Varian Medical Systems2005-03-23
TRIAGE TOX DRUG SCREEN CONTROLS (K050037)Biosite Incorporated2005-03-22
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL (K043315)Vanguard Medical Concepts, Inc.2005-03-22
VANGUARD REPROCESSED ULTRASONIC SCALPEL (K043225)Vanguard Medical Concepts, Inc.2005-03-22
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 (K050074)Welch Allyn, Inc.2005-03-22
VOYAGER PERSONAL IMAGING DEVICE (K050551)Ardent Sound, Inc.2005-03-22
LIFESTENT TURBO BILIARY STENT SYSTEMS (K050627)Edwards Lifesciences, LLC2005-03-22
GS-128 GRADIENT COMPRESSION SYSTEM (K050584)Medmark Technologies, LLC2005-03-22
ACCUHEART ELECTRODE BELT (K043361)Advanced Bioelectric Corporation2005-03-22
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML (K050400)Becton, Dickinson & CO2005-03-22
PIVOT STEERABLE MICROCATHETER (K050630)Boston Scientific - Precision Vascular2005-03-22
GLOBAL TREASURES FLUID FILLED TEETHER (K043033)Global Treasure Industries , Ltd.2005-03-22
MODIFICATION TO: EXPORT CATHETER (K050139)Medtronic Vascular2005-03-22
BASS ANTALGIC-TRAK (K042482)Traction Masters, LLC2005-03-21
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K043488)Medtronic Sofamor Danek2005-03-21
STRYKER LOCKED PLATING SYSTEM (K050512)Howmedica Osteonics Corp.2005-03-21
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV (K043497)J. Morita USA, Inc.2005-03-21
PERIOSCAN ULTRASONIC SCALER (K050354)Sirona Dental Systems GmbH2005-03-21
MODIFICATION TO: ARTHREX V-TAK (K050634)Arthrex, Inc.2005-03-21
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Every clearance here is in the API, with alerts when new ones post.