Atlas FDA

2008

3,053 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) (K080774)Terumo Cardiovascular Systems Corp.2008-04-17
SIERRA (K072729)Seaspine, Inc.2008-04-17
DIGITAL LIGHTBOX (K080608)Brainlab AG2008-04-17
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (K080525)Cook Urological, Inc.2008-04-17
LOW FLUID ALARM (K080704)Em-Tec GmbH2008-04-17
C-QUR LITE MESH V-PATCH (K080688)Atrium Medical Corp.2008-04-16
OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS (K080082)Oxlife, LLC2008-04-16
SIERRA SYSTEM (K080526)Seaspine, Inc.2008-04-16
TURBO PRIME IBD SYSTEM (K080058)Spineselect, LLC2008-04-16
ONCENTRA GYN (K080929)Nucletron Corporation2008-04-16
SURGICASE (K073449)Materialise NV2008-04-16
MANUAL RIGID MOBILITY WHEELCHAIR (K080270)Freedom Designs, Inc.2008-04-16
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES (K072814)Covidien2008-04-16
PALOMAR ASPIRE LASER PLATFORM (K080567)Palomar Medical Products, Inc.2008-04-16
C-QUR EDGE MESH V-PATCH (K080691)Atrium Medical Corp.2008-04-16
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 (K080553)Vieworks Co., Ltd.2008-04-16
RAMP INFLUENZA A/B ASSAY (K071591)Response Biomedical Corp.2008-04-16
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE (K080736)Apatech , Ltd.2008-04-16
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE (K072614)Matang Mfg. Sdn. Bhd.2008-04-15
COMPORUS (K062691)Takiron Co., Ltd.2008-04-15
DIO IMPLANT SYSTEM (K070570)Dio Department Dsi, Inc.2008-04-15
TACAHE PC1350 POWER WHEELCHAIR (K080373)Dalton Medical Corp.2008-04-14
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (K070889)Wallac OY2008-04-14
PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (K080039)G. Dundas Co.,Inc.2008-04-14
COMPUMEDICS SOMTE PSG RECORDING SYSTEM (K072201)Compumedics Limited2008-04-14
IRSG I-MOVER FOR BEDS (K072598)International Retail Services Group, LLC2008-04-14
HDL CHOLESTEROL REAGENT, MODEL 10211 (K073497)Medica Corp.2008-04-14
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD (K080308)Bioscaffold International Pte, Ltd.2008-04-14
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM (K072720)Alveolus, Inc.2008-04-11
CORAMATE/SPIROTOME SYSTEM (K080095)Medinvents2008-04-11
ULTRATEMP FIRM, FAST AND REGULAR SET (K080768)Ultradent Products, Inc.2008-04-11
LIFE+CEL OR LIFECEL BATTERY (K073716)Amco International Manufacturing & Design, Inc.2008-04-11
CEREC OPTI SPRAY (K080882)Sirona Dental Systems GmbH2008-04-11
DIO PROTEM IMPLANT SYSTEM (K080126)Dio Department Dsi, Inc.2008-04-11
IMPULSE IQ ADJUSTING INSTRUMENT (K080261)Neuromechanical Innovations, LLC2008-04-11
INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 (K073710)Intouch Technologies2008-04-11
NAVSTATIONIRAD EMT, VERSION 1.1 (K080624)Cas Innovations AG2008-04-11
ANGIOTECH CVC (K073520)Angiotech Pharmaceuticals, Inc.2008-04-11
COMPOSITE ALIGNER BUTTON (K080246)Dentsply Interntional2008-04-11
QHRV 1 - HEALTH ASSESSMENT SYSTEM (K080884)Medtechs, LLC2008-04-11
PHILIPS ECG ALGORITHM (K073376)Philips Medical Systems2008-04-11
BRIGHTVIEW VCT IMAGING SYSTEM (K080927)Philips Medical Systems (Cleveland), Inc.2008-04-11
UNIFAST III (K073106)GC America, Inc.2008-04-11
RESCUE INTERNAL IMPLANT SYSTEM (K073058)Megagen Co., Ltd.2008-04-11
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE (K072460)Abbott Vascular, Inc.2008-04-11
DARCO HEADLESS COMPRESSION SCREW (K080850)Wrightmedicaltechnologyinc2008-04-10
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 (K073219)American Medical Systems, Inc.2008-04-10
PHYSIOFLOW SYSTEM (K060387)Vasocom, Inc.2008-04-10
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM (K080185)American Medical Systems, Inc.2008-04-10
GBI TSH NEONATAL SCREENING KIT (K072458)Golden Bridge International, Inc.2008-04-10
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL (K071524)Tcm World, Inc.2008-04-10
COOLTOUCH MODELS LC215 AND COOLLIPO (K080163)New Star Lasers, Inc.2008-04-10
ELEGANCE WOMAN'S LUBRICANT (K070587)Julie Williams, Pa-C2008-04-10
INTREPID SPINAL SYSTEM (K080083)Medtronic Sofamor Danek2008-04-10
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 (K073648)Apex BioTechnology Corp.2008-04-10
CHROMOPHARE E-SERIES (K080857)Berchtold Holding GmbH2008-04-10
BAHA CORDELLE II (K080363)Cochlear Bone Anchored Systems AB2008-04-10
BOVIE IDS-400 ELECTROSURGICAL GENERATOR (K072041)Bovie Medical2008-04-10
KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT (K073590)Kronus Market Development Associates, Inc.2008-04-10
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (K080434)Smith & Nephew, Inc.2008-04-10
MODIFICATION TO:SPECIALTY NEEDLES (K073222)Busse Hospital Disposables, Inc.2008-04-09
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 (K073695)J. Morita USA, Inc.2008-04-09
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 (K080226)Hill-Rom Manufacturing, Inc.2008-04-09
IMAGENMD WITH IMAGENQ (K080770)Cardiovascular Imaging Technologies, LLC2008-04-09
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE (K080132)Thd Spa2008-04-09
PHARAON LIPO (K073617)Osyris2008-04-09
RTM AND OVAL (K080880)Next Mobility, LLC2008-04-09
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 (K080410)KARL STORZ Endoscopy-America, Inc.2008-04-09
PASS SPINAL SYSTEM (K080099)Medicrea Technologies2008-04-09
IROOT SP (K080917)Innovative Bioceramix, Inc.2008-04-09
K2M COCR ROD (K080792)K2m, Inc.2008-04-08
DENTAL DIGITAL X-RAY IMAGING SYSTEM (K073365)VATECH Co., Ltd.2008-04-08
IGROK (K080325)Igrok, LLC2008-04-08
S8 ESCAPE II (K080079)Resmed, Ltd.2008-04-08
ENTELLUS MEDICAL RS-SERIES SYSTEM (K072302)Entellus Medical, Inc.2008-04-08
PROFEMUR LX REVISION 5/8 COATED HIP STEM (K080663)Wrightmedicaltechnologyinc2008-04-08
TRICOS T RESORBABLE BONE SUBSTITUTE (K073571)Baxter Healthcare Corporation2008-04-08
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM (K073492)Tyson Bioresearch, Inc.2008-04-08
MODIFICATION TO:PILOT SPINAL SYSTEM (K080502)Life Spine2008-04-08
ZENO PMMA DISC (K080182)Wieland Dental + Technik GmbH & Co. KG2008-04-08
ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER (K080360)Endologix, Inc.2008-04-08
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K080300)Cutera, Inc.2008-04-08
VERAVIEWEPOCS (K073696)J. Morita USA, Inc.2008-04-08
CRYOSTAT (K072414)Lil Drug Store Products, Inc.2008-04-07
US/GS ULTRA WIDE SYSTEM (K073465)Osstem Implant Co., Ltd.2008-04-07
NEXCOMP AND META ETCHANT (K080305)Meta Biomed Co., Ltd.2008-04-07
LDR SPINE ROI-A IMPLANT (K080572)Ldr Spine USA2008-04-07
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER (K080697)Global USA Distribution, LLC2008-04-07
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM (K073143)Vertiflex, Inc.2008-04-07
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM (K080800)Medison Co., Ltd.2008-04-07
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 (K072885)Draeger Medical AG & Co. KG2008-04-07
ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 (K063437)Monobind, Inc.2008-04-04
VIZILITE EYEWEAR (K080043)Zila, Inc.2008-04-04
KOWA GENESIS-D (K080681)Kowa Co. , Ltd.2008-04-04
DENTAL UNIT WITH CHAIR (K080438)North West Medical Instrument (Group) Co., Ltd.2008-04-04
MODIFICATION TO: SAVI APPLICATOR KIT (K080565)Cianna Medical, Inc.2008-04-04
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE (K070217)Neuro Resource Group, Inc.2008-04-04
WELLGRAFT PE I (K072444)Gwowei Technology Co., Ltd.2008-04-04
HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 (K080827)Handan Hengyong Protective & Clean Products Co., L2008-04-04
VIVOSONIC NEUROSCREEN (K080060)Vivosonic, Inc.2008-04-04
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