Atlas FDA

2012

3,135 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CHISON DIAGNOSTIC ULTRASOUND SYSTEM (K120801)Chison Medical Imaging Co., Ltd.2012-06-14
SYNTHES SCOUT TACK FIXATION (K111048)Synthes Spine2012-06-14
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (K121442)Cordis Corporation2012-06-14
VECTOR (K121385)R4 Vascular, Inc.2012-06-14
KODAMA INTRAVASCULAR ULRASOUND CATHETER (K113008)Silicon Vally Medical Instruments, Inc.2012-06-14
TUBECLEAR (K121571)Actuated Medical, Inc.2012-06-13
EXPRESSION INFORMATION PORTAL (K121424)Invivo Corporation2012-06-13
DURABLUE STERILIZATION WRAP (K120658)Cardinal Health200, LLC2012-06-13
MEDART 620 (K120573)Medart A/S2012-06-13
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE (K121129)Spineology, Inc.2012-06-13
HONOUR SPACER SYSTEM (K120345)Nexxt Spine, LLC2012-06-13
MINI MAXLOCK EXTREME PLATING SYSTEM (K121437)Orthohelix Surgical Designs, Inc.2012-06-13
PARIETEX COMPOSITE VENTRAL PATCH (K120506)Sofradim Production2012-06-13
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS (K112897)Renovis Surgical Technologies, LLC2012-06-13
SONIXGPS NEEDLE SENSOR (K111818)Ultrasonix Medical Corporation2012-06-13
CONCIERGE GUIDING CATHETER (K121051)Merit Medical Systems, Inc.2012-06-13
AQUILION PREMIUM (K120546)Toshiba Medical Systems Corporation, Japan2012-06-13
AMPLATZER VASCULAR PLUG 4 (K113658)Aga Medical Corp.2012-06-12
MACROLYTE DISPERSIVE ELECTRODE (K120476)Conmed Corporation2012-06-12
DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT (K120695)Dentist IN A Box Pty., Ltd.2012-06-12
MULTIARRAY KIT (K121249)Paramed S.R.L.2012-06-12
RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME (K121145)Renu Medical, Inc.2012-06-12
LITECURE THERAPY COMPACT (K121487)Litecure, LLC2012-06-12
DISCOVERY CT750 HD (K120833)Ge Medical Systems, LLC2012-06-12
CONMED SUREFIT DUAL DISPERSIVE ELECTRODE (K120322)Conmed Corporation2012-06-12
MODULTH SLK (K120769)KARL STORZ Endoscopy-America, Inc.2012-06-12
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE (K120772)Zimmer GmbH2012-06-12
AGILITY (K121328)Elekta , Ltd.2012-06-12
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV (K120045)Exact Medical Manufacturing, Inc.2012-06-12
INVENT SNORING DEVICE (K120665)Ventus Medical, Inc.2012-06-12
STERILE DISPOSABLES FOR MER (K120098)Alpha Omega Engineering , Ltd.2012-06-12
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES (K113628)Catheter Robotics, Inc.2012-06-12
ARTISYN Y-SHAPED MESH (K113205)ETHICON, Inc.2012-06-11
STRYKER QUIKFLAP STERILE PROCEDURE PACK (K120352)Stryker2012-06-11
EPLUS SKIN TREATMENT SYSTEM (K113868)Syneron, Ltd.2012-06-11
DEPUT DELTA XTEND REVERSE SHOULDER (K120174)Depuy France2012-06-11
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA (K113411)Edwards Lifesciences, LLC2012-06-11
PURESLEEP (K113022)Sleep Science Partners, Inc.2012-06-11
REPROCESSED ENDOSCOPIC TROCARS (K121240)Sterilmed, Inc.2012-06-11
BLEASE700/900 SERIES VENTILATORS (K112729)Spacelabs Healthcare2012-06-11
DISPOSABLE ADHESIVE SURFACE ELECTRODE (K120494)Spes Medica Srl2012-06-11
NUCLEUS-X PTV CATHETER (DEN080015)NuMED, Inc.2012-06-11
LANO-E (K111604)Ug Global Resources Sdn. Bhd.2012-06-08
TRANSPORT CULTURE MEDIUM DEVICE (K120846)Puritan Medical Products, LLC2012-06-08
GMK - LINE EXTENSION (K120790)Medacta International2012-06-08
Q-FLO CLOSED MALE LUER CONNECTOR (K121554)Us Fusion, LLC. Dba Truecare Biomedix-USA2012-06-08
MIPAL (K120470)Watermark Medical2012-06-08
AERODR STITCHING SYSTEM (K120752)Konica Minolta Medical & Graphic, Inc.2012-06-08
TELIO CS CEM IMPLANT (K120432)Ivoclar Vivadent, AG2012-06-08
GIRAFFE BLUE SPOT PT LITE (K120820)Lumitex, Inc.2012-06-08
SIMUPLAN TREATMENT PLANNING SYSTEM (K120551)Simuplan S.L.2012-06-08
PAX-FLEX3D, PHT-7000 (K121412)VATECH Co., Ltd.2012-06-08
BELLYBOARD, SBRT ACCESSORIES (K121545)Medtec Inc. Dba Civco Medical Solutions2012-06-08
LANO-E (K111718)Ug Global Resources Sdn. Bhd.2012-06-08
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (K120624)Elcam Medical Acal2012-06-08
VIVA EB (K120334)Etview , Ltd.2012-06-08
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER (K112860)Coloplast A/S2012-06-08
EARLYSENSE (EVERON) SYSTEM (K120465)Earlysense, Ltd.2012-06-08
SCENIUM 2.0 (K121074)Siemens Medical Solutions USA, Inc.2012-06-08
AMISTEM AND QUADRA - LINE EXTENSION (K121011)Medacta International2012-06-08
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G (K121402)Trireme Medical, Inc.2012-06-08
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE (K120164)Angioslide, Ltd.2012-06-08
TUFF-TEMP 2.0 (K120784)Pulpdent Corporation2012-06-08
TBD (K120214)Lensar, Inc.2012-06-08
BAHADIR STERILIZATION TRAYS (K112090)Bahadir USA Corp.2012-06-07
VIEWFLEX XTRA ICE CATHETER (K121381)St Jude Medical2012-06-07
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... (K112607)Spinevision S.A.2012-06-07
EXPORT XT CATHETER, EXPORT AP CATHETER (K120808)Medtronic, Inc.2012-06-07
CAPSURE(R) PS SYSTEM (K120646)Spine Wave, Inc.2012-06-07
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR (K120841)Kfx Medical2012-06-07
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION (K120871)Smith & Nephew, Inc.2012-06-07
FLAT PANEL DETECTOR (K121444)Canon, Inc. - Medical Equpment Group2012-06-07
TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY (K120731)Varian Medical Systems, Inc.2012-06-06
ADAPTAIN SOLUBLE IMPLANT MATERIAL (K120220)Ceremed , Inc.2012-06-06
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM (K121064)Mako Surgical Corporation2012-06-06
ZIRCONIA BLANKS (ZIRCOSTAR) (K120852)Kerox, Ltd.2012-06-06
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA (K120552)Biocosmetics Laboratories2012-06-06
ARIATELE TELEMETRY TRANSMITTER (96281) (K121480)Spacelabs Healthcare2012-06-06
ADHERENT VISUAL STIMULATOR GOGGLES (K113785)Anschel Technology, Inc.2012-06-06
PROSOFT (K121318)Perma Laboratories2012-06-06
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF (K120987)Medtronic, Inc.2012-06-06
FORA COMFORTSCAN EAR THERMOMETER (K120712)Taidoc Technology Corporation2012-06-06
MEDCOMP VASCU-PICC & MIDLINE CATHETERS (K121094)Medical Components, Inc.2012-06-06
MULTIPURPOSE HANDLING MEDIUM (K121128)Irvine Scientific Sales Co., Inc.2012-06-06
MILLENIUM ANTI-SNORING DEVICE (K112627)Millenium Dental Laboratory, Inc.2012-06-06
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) (K121507)AtriCure, Inc.2012-06-06
LOCATOR OVERDENTURE IMPLANT SYSTEM (K120198)Zest Anchors, LLC2012-06-06
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM (K121131)Straumann USA2012-06-06
ANGIOJET SOLENT DISTA THROMBECTOMY SET (K113363)Medrad, Inc.2012-06-06
BRAIN PORT (K120691)Nico Corporation2012-06-05
HEALEX BIOSPONGE WOUND DRESSING (K112191)Bionova Medical, Inc.2012-06-05
HOMOCYSTEINE TEST (K113793)Roche2012-06-05
CENTRICITY PACS-IW (K121387)Ge Healthcare Integrated IT Solutions2012-06-05
BAUSCH + LOMB NESOFILCON A CONTACT LENS (K113703)Bausch & Lomb, Incorporated2012-06-05
ULTIMA NEO (K120054)Pain Management Technologies2012-06-05
CITIEFFE-TITANIUM CANNULATED SCREW (K113388)Citieffe2012-06-05
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION (K120759)I-Sens, Inc.2012-06-05
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM (K121515)Solta Medical, Inc.2012-06-05
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (K120303)Cybersonics, Inc.2012-06-05
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS (K120370)Zimmer, Inc.2012-06-04
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Every clearance here is in the API, with alerts when new ones post.