Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM (K070846)Prosurg, Inc.2007-07-02
CRANIAL SOLUTION ORTHOSIS (K063133)Cranial Solutions2007-07-02
DEPUY CAS HEMI ASR HIP INSTRUMENTS (K071334)DePuy Orthopaedics, Inc.2007-07-02
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S (K071645)Omron Healthcare, Inc.2007-07-02
MYLAB40 (K070903)Esaote Europe B.V.2007-07-02
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER (K071569)Biomet, Inc.2007-07-02
POWERLASER (K070516)Powermedic Aps2007-07-02
Z6 STIMULATOR (K070743)St Cardio Technologies, LLC2007-07-02
SIGMA M (K063837)Instrumentarium Dental, Palodex Group OY2007-07-02
ATLAS SPINE VERTEBRAL BODY REPLACEMENT (K071497)Atlas Spine, Inc.2007-06-29
THE INHIBITOR, MODEL 001 (K070648)Melmedtronics, Inc.2007-06-29
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT (K070613)AngioDynamics, Inc.2007-06-29
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC (K071030)Applied Dna Technologies, Inc.2007-06-29
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 (K071226)Spectranetics Corp.2007-06-29
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM (K071050)Coolsystems, Inc.2007-06-29
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS (K071024)Masimo Corporation2007-06-29
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW (K071177)Arthrex, Inc.2007-06-29
HALO360' COAGULATION CATHETER (K071543)Barrx Medical, Incorporated2007-06-29
SILHOUETTE, MODEL 1000.01 (K070426)Aranz Medical Limited2007-06-29
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER (K063526)A-M Systems, Inc.2007-06-29
SPYCATCH STONE RETRIEVAL BASKET (K071066)Boston Scientific Corp2007-06-29
AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN (K070699)Pentron Ceramics, Inc.2007-06-29
SPACE 360 DELIVERY SYSTEM (K070351)Dfine, Inc.2007-06-29
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A (K071058)Nihon Kohden America, Inc.2007-06-29
GORE BALLOON SHEATH (K070770)W. L. Gore & Associates, Inc.2007-06-29
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 (K070890)Everlife Medical Equipment Co., Ltd.2007-06-29
EMBRACE DUAL CURE COMPOSITE MATERIALS (K071278)Pulpdent Corporation2007-06-29
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION (K071090)Zimmer Trabecular Metal Technology2007-06-29
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD (K071257)Depuy Mitek, A Johnson & Johnson Company2007-06-29
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F (K071234)Siemens Medical Solutions USA, Inc.2007-06-29
NARROW NECK TEMPORARY COPING (K070744)Institut Straumann AG2007-06-29
REALHAND HIGH DEXTERITY (HD) INSTRUMENTS (K071488)Novare Surgical Systems, Inc.2007-06-29
EXPEDIUM 4.5MM SPINE SYSTEM (K071495)Depuy Spine, A Johnson & Johnson Company2007-06-29
POLYMAP PWR-08-03 (K070559)Polymap Wireless2007-06-29
PALM ECG RECORDER, MODEL EP-201/202 (K061123)Parama-Tech Company., Ltd.2007-06-29
MODIFICATION TO:SBI RINGFIX (K071394)Small Bone Innovations, Inc.2007-06-29
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (K071053)Biomet, Inc.2007-06-29
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE (K063681)Mediline Italia S.R.L.2007-06-29
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) (K070696)Interacoustics A/S2007-06-29
CERADRILL (K071352)Gebr. Brasseler GmbH & Co. KG2007-06-29
MEDICK MHM200 PERSONAL HEART MONITOR (K063339)Medick Healthcare , Ltd.2007-06-29
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG (K070921)Applied Dna Technologies, Inc.2007-06-29
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS (K071396)Capintec, Inc.2007-06-28
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT (K070786)Theken Spine, LLC2007-06-28
SMS GLUCOSE CONTROL, MODEL 2120059 (K071433)Specialty Medical Supplies2007-06-28
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM (K063670)Medtronic Sofamor Danek2007-06-28
EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT (K061239)Euroimmun Us, LLC2007-06-28
ECHELON SPECTROSCOPY PACKAGE (K071506)Hitachi Medical Systems America, Inc.2007-06-28
SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (K061496)Sa Scientific , Ltd.2007-06-28
OSSIPRO BONE SUBSTITUTE MATERIAL (K062630)Etex Corp.2007-06-28
NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL (K071611)Neocoil2007-06-28
POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING (K070619)Wrp Asia Pacific Sdn. Bhd.2007-06-27
REGIUS UNITEA (K071436)Konica Minolta Medical & Graphic, Inc.2007-06-27
GE LUNAR BODY COMPOSITION SOFTWARE (K071570)Ge Medical Systems Lunar2007-06-27
TITANIUM SCALLOPED ABUTMENT (K063768)Vident2007-06-27
EZPACS, VERSION 3.0 (K062878)Advanced Imaging Solutions, LLC2007-06-27
HABIB HEXABLATE (K071103)Emcision , Ltd.2007-06-27
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM (K070572)Ash Access Technology, Inc.2007-06-26
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 (K071319)Bio-Rad, Diagnostics Grp.2007-06-26
MASSAGE MATTRESS VM9100RM (K070672)Metek GmbH2007-06-26
ASA01 HEAVY DUTY SUCTION PUMP (K071607)Zhongshan A&J Medical Equipment Co., Ltd.2007-06-26
INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K071513)Siemens Medical Solutions2007-06-26
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE (K071268)Dade Behring, Inc.2007-06-26
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (K070849)DePuy Orthopaedics, Inc.2007-06-26
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 (K071523)Genexel-Sein, Inc.2007-06-26
PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS (K070791)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-06-26
BONALIVE GRANULES AND BONALIVE PLATES (K070055)Vivoxid , Ltd.2007-06-25
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, (K070819)Bio-Rad Laboratories Inc., Clinical Systems Divisi2007-06-25
EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER (K063376)Medica Corp.2007-06-25
SMALL STATURE SPACERS (K063393)Biomet Spine2007-06-25
MAMMAPRINT (K070675)Agendia BV2007-06-22
TRIFLEX SELECT (K070647)Cardinal Health, Inc.2007-06-22
BLUGOO HD (K071192)Lancer Orthodontics, Inc.2007-06-22
OTOMEDICS SOFT TYMPANOSTOMY TUBE (K071178)Otomedics Advanced Medical Technologies, Ltd.2007-06-22
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM (K071184)Synthes (Usa)2007-06-22
ARX-LINK CROSS CONNECTOR (K070995)Life Spine2007-06-22
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM (K070524)Cambridge Sensors Limited2007-06-22
SILICONE TISSUE EXPANDER (K070303)Specialty Surgical Products2007-06-22
ATLANTIS ABUTMENT FOR ASTRA IMPLANT (K070833)Atlantis Components, Inc.2007-06-22
ENZYMATIC CREATININE ASSAY (265 SERIES) (K070383)Diagnostic Chemicals , Ltd.2007-06-22
POWDERED LATEX EXAMINATION GLOVES (K071323)Quality Gallant Sdn. Bhd.2007-06-22
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO (K071025)Zoll Medical Corporation, World Wide Headquarters2007-06-22
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM (K063388)Topcon Corp.2007-06-22
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA (K071064)Ascension Orthopedics, Inc.2007-06-22
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) (K071297)Agfa Healthcare Corp.2007-06-22
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM (K071401)Imaging Dynamics Company , Ltd.2007-06-22
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT (K071002)Beckman Coulter, Inc.2007-06-21
SYNERAD OMNI, MODELS AN6255 AND AN6265 (K071430)Analogic Corp.2007-06-21
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER (K062372)The Binding Site, Ltd.2007-06-21
ST AIA-PACK INTACT PTH ASSAY (K063605)Tosoh Bioscience, Inc.2007-06-21
ENDOSSEOUS DENTAL IMPLANT SYSTEM (K070841)Southern Implants, Inc.2007-06-21
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 (K070491)K-Jump Health Co., Ltd.2007-06-21
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 (K070941)Taidoc Technology Corporation2007-06-21
SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES (K070975)Hu-Friedy Mfg. Co., Inc.2007-06-21
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST (K070660)Alfa Scientific Designs, Inc.2007-06-21
SKATER BILIARY CATHETER (K070610)Angiotech2007-06-21
PRELUDE SHEATH INTRODUCER (K070159)Merit Medical Systems, Inc.2007-06-21
TOPICAL APPLICATOR (K070596)Sharn, Inc.2007-06-21
FLEXGUARD (K070924)Allmed Systems, Inc.2007-06-21
BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS (K070533)B.T.I. Biotechnology Institute, Sl.2007-06-21
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