Atlas FDA

2006

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

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RecordFirmDate
THE DOUBLE GLOVE (K060030)Biobarrier, Inc.2006-06-27
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME (K061684)Medi-Globe Corporation2006-06-27
ZIMMER CONTOUR RESTORATIVE SYSTEM (K061043)Zimmer Dental, Inc.2006-06-27
AUTOBONE2 (K061625)GE Healthcare2006-06-26
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (K061159)Hospira, Inc.2006-06-26
BLOOD PRESSURE METER, MODEL CH-311B (K061161)Citizen Watch Co., Ltd.2006-06-26
PRE-IMPRESSION CONDITIONING SOLUTION (K061427)Dentsply Intl.2006-06-26
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (K051573)Dr. Howard Martin, P.A.2006-06-26
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE (K061487)Collagen Matrix, Inc.2006-06-26
ALLWOUND (K053476)At Squared, LLC2006-06-26
RANGER IRRIGATION FLUID WARMING SYSTEM (K060939)Arizant Healthcare, Inc.2006-06-26
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 (K060243)Olympus Medical Systems Corporation2006-06-23
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM (K061034)Respironics, Inc.2006-06-23
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 (K052908)Infraredx, Inc.2006-06-23
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM (K060483)Volcano Corporation2006-06-23
EMJOI TENS DEVICE (K052711)Emjoi, Inc.2006-06-23
AFIBALERT ATRIAL FIBRILLATION DETECTOR (K052767)Lechnologies Research, Inc.2006-06-23
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM (K061301)Copan Diagnostics, Inc.2006-06-23
SPIDERX EMBOLIC PROTECTION DEVICE (K053195)Ev3, Inc.2006-06-23
EBI ARRAY SPINAL SYSTEM (K061563)Ebi, L.P.2006-06-23
PILOT TEST OR DETECTIVE AUDIOMETERS (K060883)Interacoustics A/S2006-06-23
ACELL POWDER WOUND DRESSING (K060888)Acell, Inc.2006-06-23
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING (K060509)Tyco Healthcare Group2006-06-23
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 (K061254)Medtronic Perfusion Systems2006-06-23
ZIMMER COLLAGEN REPAIR PATCH (K053562)Tissue Science Laboratories, Plc2006-06-23
VS-800 VITAL SIGNS MONITOR (K060281)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-06-23
FULLCARD ANALYSIS (K061587)GE Healthcare2006-06-23
SMART USBLITE, MODEL M011120 (K061443)Intelligent Hearing Systems2006-06-23
CALSET COMPOSITE HEATER (K061395)Addent, Inc.2006-06-23
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU (K061302)Mitsubishi Electric Corporation Kyoto Works2006-06-23
VIPER SPINE SYSTEM (K061520)Depuy Spine, Inc.2006-06-23
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 (K060900)Spacelabs Medical, Inc.2006-06-23
BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 (K061038)Barriermed Glove Co.2006-06-23
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS (K060316)Fresenius Kabi Deutschland GmbH2006-06-23
BREAS ISLEEP 20+ (K061057)Breas Medical AB2006-06-23
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY (K060745)Asahi Intecc Co., Ltd.2006-06-23
CREATININE (K061193)Abbott Laboratories, Inc.2006-06-23
HI-TORQUE WHISPER VIEW GUIDE WIRE (K061453)Guidant Corp.2006-06-22
TRIAGE TOX DRUG SCREEN, MODEL 94400 (K060791)Biosite Incorporated2006-06-22
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K061157)Bausch & Lomb2006-06-22
LUNG FLUTE (K060439)Medical Acoustics, LLC2006-06-22
NEMIO XG, SAA-580A (K061605)Toshiba America Medical Systems, In.C2006-06-22
4CIS VANE SPINE SYSTEM (K060702)Solco Biomedical Co., Ltd.2006-06-22
AG-PLUS, MODEL 91210 (K060404)Medel S.P.A.2006-06-22
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES (K061120)Synergeyes, Inc.2006-06-22
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (K061503)Dade Behring, Inc.2006-06-22
ILED (K061317)Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg2006-06-22
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR (K061456)A&D Engineering, Inc.2006-06-21
REVJET TURBO (K060842)Promedic, Inc.2006-06-21
CONFIDENCE HIGH VISCOSITY BONE CEMENT (K060300)Disc-O-Tech Medical Technologies, Ltd.2006-06-21
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 (K061024)Peregrine Surgical , Ltd.2006-06-21
DEPOTONE (K061032)Imprint Pharmaceuticals Limited2006-06-21
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR (K061205)Medela AG2006-06-21
DEFIBRILLATOR CABLE TESTER, MODEL DT2200 (K061606)Medical Devices/Padpro, Inc.2006-06-21
SMDIE DEVICE INTERFACING SYSTEM (K061590)Siemens Medical Solutions Health Services Corporat2006-06-21
SOYALA, SOYALA BLUE (K060405)Weinmann Gerate Fur Medizin GmbH + Co. KG2006-06-21
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 (K061546)Maquet Cardiopulmonary, AG2006-06-20
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 (K061089)Biopro, Inc.2006-06-20
NANOLITE SKIN CARE SYSTEM (K061117)Nanolite Technology, Inc.2006-06-20
VITEK 2 GRAM POSITIVE VRSA SCREEN (K061347)bioMerieux, Inc.2006-06-20
ENDOSSEOUS DENTAL IMPLANT (K061169)Northern Implants, LLC2006-06-20
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 (K061324)Rtc Inc.-Memcath Technologies, LLC2006-06-20
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT (K060510)Drew Scientific , Ltd.2006-06-19
ACUMEN SINGLE-LUMEN DELIVERY SHEATH (K053400)Acumen Medical, Inc.2006-06-19
MULTI-USE ELECTRONIC PREGNANCY TEST (K060825)Mizuho USA, Inc.2006-06-19
POINTER PLUS (K060508)Lhasa Oms, Inc.2006-06-19
US SPINE FACET FIXATION SYSTEM (K061041)Us Spine2006-06-19
3M LIQUID BANDAGE (K053409)3M Company2006-06-19
CARTO RMT EP NAVIGATION SYSTEM V8 (K060047)Biosense Webster, Inc.2006-06-19
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM (K061203)Ziehm Imaging, Inc.2006-06-19
MEDLINE COLLAGEN WOUND DRESSING (K060456)Medline Industries, Inc.2006-06-19
CUTICOVER SKIN BARRIER DEVICE (K042955)D & D Holdings, LLC2006-06-19
INSIGHT HEAD COIL (K061281)Insight Neuroimaging Systems, LLC2006-06-19
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT (K060945)Smiths Medical International2006-06-19
POINTER EXCEL (K060517)Lhasa Oms, Inc.2006-06-19
ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 (K060431)Mbl International Corporation2006-06-19
ACUTE BONE SCREW (K061206)Acute Innovations, LLC2006-06-19
IMPLANTIUM II (K060501)Dentium Co., Ltd.2006-06-16
OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM (K051965)Merete Medical GmbH2006-06-16
EZ SMART-168 GLUCOSE MONITORING SYSTEM (K052818)Tyson Bioresearch, Inc.2006-06-16
SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET (K061409)Precise Medical Products, Ltd.2006-06-16
COOL.CLICK 2 (K060819)Medical House Products Limited2006-06-16
LNCS AND SPO2.COM SENSORS (K060143)Masimo Corporation2006-06-16
SPEEDY ORTHODONTIC SCREW (K060500)Dentium Co., Ltd.2006-06-16
SNAP II EEG MONITOR (K060997)Everest Biomedical Instruments Co.2006-06-15
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE (K053381)Welch Allyn, Inc.2006-06-15
CMB ANTIMICROBIAL DRESSING (K060237)Silverleaf Medical Products, Inc.2006-06-15
RAPIDONE-COCAINE-150 TEST (K053422)American Bio Medica Corp.2006-06-15
MILAGRO INTERFERENCE SCREW (K060830)Depuy Mitek, A Johnson & Johnson Company2006-06-15
MULTIGENT GENTAMICIN (K060709)Seradyn, Inc.2006-06-15
OMNILINK. 018 BILIARY STENT SYSTEM (K060817)Guidant Endovascular Solutions, Inc.2006-06-15
CZ-S2000 (K060946)Parkell, Inc.2006-06-15
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 (K061464)Ortho-Clinical Diagnostics, Inc.2006-06-15
ENSEAL PTC TISSUE SEALING DEVICE (K061526)Surgrx, Inc.2006-06-15
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE (K060364)Teco Diagnostics2006-06-15
APEX KNEE SYSTEM (K060192)Omni Life Science, Inc.2006-06-15
DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES (K060524)Dolphin Medical, Inc.2006-06-15
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA (K060876)Disetronic Medical Systems AG2006-06-15
ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 (K053037)Acro Biotech, LLC2006-06-15
IR PRO 250 (K061080)Lhasa Oms, Inc.2006-06-14
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Every clearance here is in the API, with alerts when new ones post.