Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TIANJIN MEDIS DISPOSABLE INFUSION SET (K060082)Tianjin Medis International Trade Co., Ltd.2006-03-31
ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM (K060269)Acmi Corporation2006-03-31
E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE (K060255)E Surgical, LLC2006-03-31
NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES (K060634)Abbott Spine, Inc.2006-03-31
RX IMOLA (K052914)Randox Laboratories, Ltd.2006-03-31
GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX (K060542)General Electric Co.2006-03-31
ETI-MAX 3000 (K052794)DiaSorin, Inc.2006-03-31
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE (K053366)Pt Mahakarya Inti Buana2006-03-30
VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS (K060303)Biomet Manufacturing Corp2006-03-30
FIBER-METAL POST (K060075)Foremost Dental, LLC2006-03-30
ATRIUM FLIXENE GRAFT (K060124)Atrium Medical Corp.2006-03-30
RF TUNNELER WIRE (K051670)Baylis Medical Co., Inc.2006-03-30
SBI RADIO-CAPITELLAR IMPLANT (K060038)Small Bone Innovations, Inc.2006-03-30
P-STIM SYSTEM (K050123)Neuroscience Therapy Corp.2006-03-30
PM-50 PULSE OXIMETER (K052693)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-03-30
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA. (K060493)Becton, Dickinson & CO2006-03-29
PILL PHONE (K060298)Vocel2006-03-29
PRE-POWDERED STERILE VINYL GLOVE, CLEAR (K053521)Shijiazhuang Hongxiang Plastics Products Co., Ltd.2006-03-29
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K051058)Lin-Zhi International, Inc.2006-03-29
BISCO LED (K052122)Bisco, Inc.2006-03-29
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 (K060074)Baxter Healthcare Corp2006-03-29
INNOCURE IMRT FILTER (COMPENSATORS) (K052383)Innocure, LLC2006-03-29
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (K060332)Isotis NV2006-03-29
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H (K052788)Dade Behring, Inc.2006-03-29
FRAXEL II SR LASER SYSTEM AND ACCESSORIES (K060310)Reliant Technologies, Inc.2006-03-29
FIDIS CELIAC (K053383)Biomedical Diagnostics (Bmd) SA2006-03-29
O-ARM IMAGING SYSTEM (K060344)Breakaway Imaging, LLC2006-03-29
VOXAR 3D ENTERPRISE, MODEL 6.1 (K060505)Barcoview Mis Edinburgh2006-03-29
ACCU-SOURCE (K051753)Oncology Systems, Inc.2006-03-29
INTERX500 FLEXIBLE ARRAY ELECTRODE (K053626)Neuro Resource Group, Inc.2006-03-29
ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 (K060197)Zargis Medical Corp.2006-03-29
ACCESS BREAST COIL 4/SMS (K060547)Confirma, Inc.2006-03-29
PEDIATRIC URETERAL STENT (K060673)Applied Medical Resources Corp.2006-03-29
CLEANSE S+ ULTRASONIC SCALER (K060171)Dmetec.Co., Ltd.2006-03-29
PD CATH (K053123)Med-Conduit, Inc.2006-03-29
INTERPROXIMAL REDUCTION SYSTEM (K053368)Dentsply International2006-03-29
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS (K050945)Lin-Zhi International, Inc.2006-03-29
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS (K052525)DFI Co., Ltd.2006-03-29
PTA (PROGRESSIVE TIBIAL ALIGNMENT) (K060403)Meridian Medical2006-03-28
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN (K053072)Dade Behring, Inc.2006-03-28
POREX ELECTROSURGERY NEEDLE (K052297)Porex Surgical, Inc.2006-03-28
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE (K060528)Aesculap, Inc.2006-03-28
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 (K053079)Hypoguard USA, Inc.2006-03-28
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN (K053073)Dade Behring, Inc.2006-03-28
VITAMESH MACROPOROUS PP SURGICAL MESH (K060520)Proxy Biomedical , Ltd.2006-03-28
ACULIFE, MODEL SMW-01 (K051197)Inno-Health Technology, Inc.2006-03-28
OPTIBOND ALL-IN-ONE (K060469)Sybron Dental Specialties, Inc.2006-03-28
SYVEKEXCEL (K053300)Marine Polymer Technologies, Inc.2006-03-28
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM (K060523)Cyberkinetics, Inc.2006-03-28
COULTER 5C CELL CONTROL (K060464)Beckman Coulter, Inc.2006-03-28
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 (K060543)Clinical Micro Sensors, Inc.2006-03-28
IQMARK EZ STRESS (K052898)Brentwood Medical Technology Corp.2006-03-28
HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL (DEN050007)Fmg Innovations, Inc.2006-03-27
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM (K060120)Teco Diagnostics2006-03-27
ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (K060306)Isotis NV2006-03-27
ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 (K060215)Eurotrol B.V.2006-03-24
FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM (K053384)Astra Tech, Inc.2006-03-24
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (K053401)Arkray, Inc.2006-03-24
TITAN GUIDEWIRE (K060454)Lake Region Mfg., Inc.2006-03-24
VERIFY 3-10 MIN FLASH INTEGRATOR (K060066)Albert Browne , Ltd.2006-03-24
THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS (K060541)Philips Medizin Systeme Boblingen GmbH2006-03-24
ISIGHT IMAGING CATHETER, MODEL 38986 (K060175)Boston Scientific Corp2006-03-24
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (K052891)Hawken Industries2006-03-23
KHAN KINETIC TREATMENT DEVICE (KKT-M1) (K060043)Optima Health Solutions International, Inc.2006-03-23
DEPUY PFC SIGMA KNEE PROSTHESIS (K060515)DePuy Orthopaedics, Inc.2006-03-23
IPLAN FLOW (K053164)Brainlab AG2006-03-23
PALOMAR LUX1540 HANDPIECE (K060301)Palomar Medical Technologies, Inc.2006-03-23
CYCLONE, MODEL MAICAM 180 (K060486)Spectrica2006-03-23
BD AUTOSHIELD PEN NEEDLE (K060007)Becton, Dickinson & CO2006-03-23
DOPPLEX CENTRALE (K060230)Huntleigh Healthcare , Ltd.2006-03-23
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C (K053360)Aerovectrx Corporation2006-03-23
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM (K060487)Edwards Lifesciences, LLC2006-03-23
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML) (K060312)Dade Behring, Inc.2006-03-23
OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE (K053494)Fertipro NV2006-03-23
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS (K053229)Merits Health Products Co., Ltd.2006-03-23
SEMPERFLO INFUSION SYSTEM (K052999)ETHICON, Inc.2006-03-22
M-VU VIEWER STATION (K060451)Vucomp, Inc.2006-03-22
SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM (K051510)Signal Medical Corp.2006-03-22
RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM (K060411)Radiancy (Israel) , Ltd.2006-03-22
DIAPHYSEAL PLATE (K060294)Hand Innovations, LLC2006-03-22
HSINER RESUSCITATOR (K053466)Hsiner Co., Ltd.2006-03-22
EXCIA TOTAL HIP SYSTEM WITH U-CAP (K060437)Aesculap, Inc.2006-03-22
ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM (K060239)Alveolus, Inc.2006-03-22
CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED (K060322)Cliniqa Corporation2006-03-21
MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (K060417)Quantimetrix Corp.2006-03-21
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS (K060121)Biomet Manufacturing Corp2006-03-21
A.B. DENTAL DEVICES (K051719)A.B. Dental Devices , Ltd.2006-03-21
AFT ALLOGRAFT FILLER TUBE (K060161)Musculoskeletal Transplant Foundation2006-03-21
MISSION COMPLETE (K060206)Diamond Diagnostics, Inc.2006-03-21
APOLLO IR HEAT LAMP SYSTEM (K060134)Apollo Physical Therapy Products International2006-03-21
EVERSTICK A&O (K051953)Stick Tech , Ltd.2006-03-21
NORIAN SRS BONE VOID FILLER (K060408)Synthes (Usa)2006-03-21
INQUIRY AFOCUS II DIAGNOSTIC CATHETER (K053582)Irvine Biomedical, Inc.2006-03-21
PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 (K060304)Biotex, Inc.2006-03-21
NORIAN SRS FAST SET PUTTY (K060406)Synthes (Usa)2006-03-20
MULTISTAR (K060455)Asclepion Laser Technologies GmbH2006-03-20
STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM (K060156)I.T.S. Implantat-Technologie-Systeme GmbH2006-03-20
QUADROSTAR 532 (K060457)Asclepion Laser Technologies GmbH2006-03-20
KAVS - CATHETER, MODELS 1107100 & 1107060 (K052844)Richter & Rothe AG2006-03-20
FRAXEL SR LASER SYSTEM (K053047)Reliant Technologies, Inc.2006-03-20
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Every clearance here is in the API, with alerts when new ones post.