Atlas FDA

2007

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

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RecordFirmDate
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 (K061812)Analyticon Biotechnologies AG2007-04-06
3M TEGADERM CHG DRESSING (K063458)3M Company2007-04-05
CES ULTRA (K062284)Neuro-Fitness, LLC2007-04-05
CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 (K070680)Cardiomems, Inc.2007-04-05
MINI LAP INSTRUMENTS (K070686)Mini Lap Technologies, Inc.2007-04-05
FLUOROPRO RF DIGITAL IMAGING SYSTEM (K070390)Virtual Imaging, Inc.2007-04-05
MODIFICATION TO: VELSCOPE (K070523)Led Dental, Inc.2007-04-05
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT (K070738)Cook Biotech, Inc.2007-04-05
GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER (K070657)Getinge Sourcing, LLC2007-04-05
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM (K070211)Hemostasis, LLC2007-04-05
CAPSURE PEDICLE SCREW SYSTEM (K070245)Spine Wave, Inc.2007-04-05
MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM (K070352)Mini Lap Technologies, Inc.2007-04-05
ARGOS (K061479)3D Line Medical Systems S.R.L.2007-04-05
KRYSTAL-X WIFI (K070505)Owandy2007-04-05
DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM (K070658)E-Woo Technology2007-04-05
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 (K070221)Encore Medical L.P.2007-04-04
POWERGROSHONG PICC CATHETER (K063848)C.R. Bard, Inc.2007-04-04
BIOLUCENT APPLICATOR KIT (K070659)Biolucent, Inc.2007-04-04
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS (K070430)Unomedical A/S2007-04-04
CVS PERSONAL LUBRICANT AND MOISTURIZER (K062682)Lake Consumer Products, Inc.2007-04-04
ELIBRA DYNAMIC KNEE BALANCER (K070108)Synvasive Technology, Inc.2007-04-04
TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K063728)Alfa Tech Medical Systems, Ltd.2007-04-04
ZYGOMA IMPLANT (IMMEDIATE FUNCTION) (K070182)Nobel Biocare AB2007-04-04
SPINAL STABILIZING SPHERE SYSTEM (K063139)Biomet Spine2007-04-04
QUANTA LITE SS-A 52 ELISA (K063565)Inova Diagnostics, Inc.2007-04-04
SYNFIX -LR (K062083)Synthes Spine Co.Lp2007-04-03
MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM (K070273)Nuvasive, Inc.2007-04-03
CORIN UNIPOLAR MODULAR HEAD (K063791)Corin USA2007-04-03
PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 (K062963)Ra Medical Systems,Inc2007-04-03
ECHO BI-METRIC PRESS-FIT STEMS (K070274)Biomet Manufacturing Corp2007-04-03
WU'S POWERED WHEELCHAIR, MAMBO 36 (K070655)Wu'S Tech Co., Ltd.2007-04-02
C.T.M. MOBILITY SCOOTER# HS-265 (K070602)C.T.M. Homecare Product, Inc.2007-04-02
RESCUE INTERNAL IMPLANT SYSTEM (K063216)Megagen Co., Ltd.2007-04-02
FASTPACK TOTAL PSA METHOD VERIFICATION KIT (K062957)Qualigen, Inc.2007-04-02
STERILOX LIQUID CHEMICAL STERILANT SYSTEM (K063159)Puricore, Inc.2007-04-02
LYPHOCHEK DIABETES CONTROL (K070546)Bio-Rad Laboratories2007-04-02
BLUE SHARK (K070016)Meridan Medical2007-04-02
FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE (K070673)Teleflexmedical, Inc.2007-04-02
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS (K070644)W. L. Gore & Associates, Inc.2007-04-02
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (K063061)Viasys Medsystems2007-04-02
CONMED LINVATEC SMART GUARD IRRIGATOR (K070233)Conmed Linvatec2007-04-02
D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 (K063321)Neks Technologies, Inc.2007-03-30
ALPHA BIO BONE FIXATION SCREW SYSTEM (K063769)Alpha-Bio Tec , Ltd.2007-03-30
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE (K063674)Animas Corp.2007-03-30
IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (K050415)Impedimed Pty , Ltd.2007-03-30
CISBIO RENIN RIA TEST (K062120)Cis Bio International2007-03-30
TOKUYAMA BOND FORCE (K070215)Tokuyama Dental Corporation2007-03-30
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM (K070729)Fall Prevention Technologies, LLC2007-03-30
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM (K070551)Pioneer Surgical Technology2007-03-29
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER (K063076)Ascent Healthcare Solutions2007-03-29
DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM (K063874)Blue Sky Bio, LLC2007-03-29
COE SOFT (K070697)GC America, Inc.2007-03-29
COE COMFORT (K070698)GC America, Inc.2007-03-29
HEMOSIL PROCLOT (K070635)Instrumentation Laboratory CO2007-03-29
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES (K070177)Fresenius Medical Care North America2007-03-29
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 (K070127)Kevin Vu, Dds2007-03-29
NEWDEAL COMPRESSION PLATE (K070447)Newdeal Sas2007-03-29
MODIFICATION TO: LIGAFIX INTERFERENCE SCREW (K070507)Science For Biomaterials2007-03-29
R&D SICKLE QC CONTROL (K070334)R&D Systems, Inc.2007-03-29
MODIFICATION TO POLAR CARE 500 (K070402)Breg, Inc.2007-03-29
MA 55 MAESTRO (K063452)Maico Diagnostics (Diagnostic Group, LLC)2007-03-29
ARGON CONTINUOUS FLUSH DEVICE (K070384)Argon Medical Devices, Inc.2007-03-29
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER (K070525)Wrightmedicaltechnologyinc2007-03-29
C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM (K070548)Cardica, Inc.2007-03-29
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K070041)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-28
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES (K070208)Synthes (Usa)2007-03-28
MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM (K070712)Surgical Innovations Group Plc2007-03-28
TR BAND (K070423)Terumo Medical Corp.2007-03-28
MODIFICATION TO HEALTH BUDDY APPLIANCE (K070543)Health Hero Network, Inc.2007-03-28
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (K061377)Pointe Scientific, Inc.,2007-03-28
MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION (K070052)Vilex, Inc.2007-03-28
ECG CABLES, TRUNK AND PATIENT LEAD WIRES (K070232)American I.V. Products, Inc.2007-03-27
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY (K063090)Medrad, Inc.2007-03-27
CUTERA ER:YSGG LASER HANDPIECE (K063867)Cutera, Inc.2007-03-27
MOORLD12-B1 LASER DOPPLER BURNS IMAGER (K060976)Moor Instruments, Ltd.2007-03-27
CERNER PROVISION WORKSTATION (K070394)Cerner Corp.2007-03-27
MONARCH III IOL DELIVERY SYSTEM (K063155)Alcon Manufacturing, Ltd.2007-03-27
MODIFICATION TO: OCU-FILM TIP COVER (K070534)Reichert, Inc.2007-03-27
DIGORA PCT/DIGIPOD (K070304)Soredex Palodex Group OY2007-03-27
CUTERA ER:YAG LASER HANDPIECE (K070138)Cutera, Inc.2007-03-27
REVOLIX 120 (K070476)Allmed Systems, Inc.2007-03-26
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE (K070169)KLS Martin L.P.2007-03-26
DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE (K070407)Dukal Corp.2007-03-26
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR (K063442)Degania Silicone , Ltd.2007-03-26
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM (K063770)Alpha-Bio Tec , Ltd.2007-03-26
BANANA RIBBED (K063401)Medtech Products , Ltd.2007-03-26
ACUSON X150 ULTRASOUND SYSTEM (K070576)Siemens Medical Solutions USA, Inc.2007-03-26
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K070404)Tangshan Luxiong Plastic Products Co., Ltd.2007-03-26
FLEX AND LOOP COIL SET 1.5 T (K070629)Siemens Medical Solutions2007-03-26
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS (K063864)Medical Electronic Systems , Ltd.2007-03-26
ZIRBLANK-PS AND ZIRBLANK-FS (K070045)Acucera, Inc.2007-03-26
SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 (K070142)Bio-Medical Research Corp.2007-03-23
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K070526)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-03-23
BP 101 DIGITAL BLOOD PRESSURE MONITOR (K062033)Kingyield Hongkong Limited2007-03-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW (K070038)Super Safe Plastic Products Co., Ltd.2007-03-23
CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS (K070542)Digirad Corp.2007-03-23
IMPLANT SCIENCES CORP. MODEL HDR 4454 (K070468)Implant Sciences Corp.2007-03-23
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT (K070493)Heartway Medical Products Co., Ltd.2007-03-23
OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804)Olympus America, Inc.2007-03-23
ZIOSTATION (K070205)Ziosoft, Inc.2007-03-23
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Every clearance here is in the API, with alerts when new ones post.