Atlas FDA

2013

3,052 FDA 510(k) clearances · Clearance year

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RecordFirmDate
POLARUS CONNECT (K131636)Acumed, LLC2013-10-10
T2 TIBIAL NAILING SYSTEM (K131365)Stryker Trauma AG2013-10-10
PEERSCOPE SYSTEM (K131422)Endochoice, Inc.2013-10-10
VITEK 2 AST-ST TIGECYCLINE (K131779)bioMerieux, Inc.2013-10-10
BIOLOX(R) DELTA CERAMIC HEADS (K131684)Biomet, Inc.2013-10-10
NXSTAGE CONNECTED HEALTH SYSTEM (K131739)Nxstage Medical, Inc.2013-10-10
BARRICADE EMBOLIZATION COIL SYSTEM (K132482)Blockade Medical2013-10-10
IMPLANET SPINE SYSTEM (K132303)Implanet, S.A.2013-10-10
3B LASER NEEDLE (K131797)Livetec GmbH2013-10-10
DELTEX MEDICAL CARDIOQ-EDM+ (K132139)Deltex Medical Limited2013-10-10
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA (K130728)Smith & Nephew, Inc.2013-10-10
ROLLINS 7 OXYGEN MASK (K130379)Rollins Medical Solutions, Inc.2013-10-09
CEZANNE II INTERBODY FUSION SYSTEM (K131981)Accel Spine2013-10-09
HAMILTON-G5 (K131774)Hamilton Medical AG2013-10-09
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER (K131207)Surgical Instrument Engineering AG2013-10-09
AU BICARBONATE REAGENT (K131546)Beckman Coulter Ireland, Inc.2013-10-09
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (K132819)Playtex Manufacturing, Inc.2013-10-09
SYNERGY ODM (K132667)Topcon Medical Systems, Inc.2013-10-09
COMPREHENSIVE CONVERTIBLE GLENOID (K130390)Biomet Manufacturing, Inc.2013-10-09
VIDAS C DIFFICILE GDH (K132010)Biomerieux S.A.2013-10-09
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW (K132704)Biomet2013-10-09
ESOPHAGEAL TTS STENT (K123205)Taewoong Medical Co., Ltd.2013-10-09
WECK EFX ENDO FASCIAL CLOSURE SYSTEM (K132362)Teleflexmedical, Inc.2013-10-08
APEX KNEE MODULAR TIBIA SYSTEM (K131472)Omni Life Science, Inc.2013-10-08
NERIA SOFT 90 INFUSION SET (K132142)Unomedical A/S2013-10-08
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT (K131015)Cook Biotech, Inc.2013-10-08
INTEL-GE CARE INNOVATIONS QUIETCARE (K131585)Intel-Ge Care Innovations, LLC2013-10-08
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM (K131186)Synthes (USA) Products, LLC2013-10-08
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE (K131353)Biomet Manufacturing Corp2013-10-08
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) (K132589)Life Spine, Inc.2013-10-08
MEDDUSA BIPOLAR SYSTEM (K130110)Elliquence, LLC2013-10-08
PRONTOSAN WOUND GEL X (K130857)B.Braun Medical, Inc.2013-10-08
INMODE WMBODY DEVICE (K131362)Inmode MD , Ltd.2013-10-08
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS (K132829)Maquet Cardiopulmonary, AG2013-10-08
R7 (K130834)Cefla S.C.2013-10-08
CD HORIZON SPINAL SYSTEM (K132471)Medtronic Sofamor Danek USA, Inc.2013-10-08
UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES (K132224)Unimed Surgical Products, Inc.2013-10-08
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS (K132734)Baxter Healthcare Corp2013-10-08
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET (K131201)Cook, Inc.2013-10-07
PHILIPS PIXIUM 4343RC (K131483)Philips Medical Systems Dmc GmbH2013-10-07
VISI MOBILE MONITORING SYSTEM (K130709)Sotera Wireless, Inc.2013-10-07
HEM-6221 (K131749)Omron Healthcare, Inc.2013-10-07
TRELLIS COLLAGEN RIBBON (K131143)Wrightmedicaltechnologyinc2013-10-07
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) (K131645)Alfa Scientific Designs, Inc.2013-10-07
CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM (K131769)Pivot Medical, Inc.2013-10-07
ESTECH COBRA(R) GENESIS BIPOLAR CLAMP (K133017)Estech, Inc.2013-10-07
KYMCO EQ20C SCOOTER (K130940)Kwang Yang Motor Co., Ltd.2013-10-07
CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES (K131771)Thermomedics, Inc.2013-10-07
ESOFLIP BALLOON DILATION CATHETER (K132337)Crospon, Ltd.2013-10-07
V8 SP NORMAL CONTROL, ABNORMAL CONTROL (K131479)Helena Laboratories2013-10-07
INNER PEACE (K122800)Kamabry, Inc., Dba Inner Peace For Women2013-10-04
PATHFAST CK-MB-II CALIBRATORS (K130628)Mitsubishi Chemical Medience Corporation2013-10-04
S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K132768)Sonoscape Company Limited2013-10-04
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM (K132861)Samsung Medison Co., Ltd.2013-10-04
STAXX IBL SYSTEM (K132719)Spine Wave, Inc.2013-10-04
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER (K132905)Arteriocyte Medical Systems, Inc.2013-10-04
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (K132645)Medtronic, Inc.2013-10-04
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G (K131820)Care Fusion2013-10-04
VITAHEAT PATIENT WARMING SYSTEM (K132454)Vitaheat Medical, LLC2013-10-04
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (K131709)Arthrocare Corp.2013-10-04
MICROPLEX COIL SYSTEM (MCS) (K131948)MicroVention, Inc.2013-10-04
ISCHEMA VIEW RAPID (K121447)Ischemaview, Inc.2013-10-04
SMARTSITE VIALSHIELD (K132863)Yukon Medical, LLC2013-10-04
XPRESS MULTI-SINUS DILATION TOOL (K132440)Entellus Medical, Inc.2013-10-04
LOCKING PLATE SYSTEM (K132642)Beijing Libeier Bio-Engineering Institute Co., Ltd.2013-10-03
BEAUTIFIL BULK FLOWABLE (K132141)Shofu Dental Corporation2013-10-03
NEO KNEE SYSTEM (K131368)Pipeline Orthopedics2013-10-03
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES (K122557)Shanghai Motex Healthcare Co., Ltd.2013-10-03
AVAFLEX VERTEBRAL BALLOON SYSTEM (K131824)Care Fusion2013-10-03
DICOM VIDEO (K132183)Bar Code Computer, Ltd.2013-10-03
AMCAD-UT DETECTION MODEL 2.0 (K122536)Lin & Associates, LLC2013-10-03
PICCOLO COMPOSITE NAILING SYSTEM (K132774)CarboFix Orthopedics , Ltd.2013-10-03
THERMOCHEM HT-2000 (K131583)Thermasolutions, Inc.2013-10-03
OCCLUSION PERFUSION CATHETER (K130525)Advanced Catheter Therapies, Inc.2013-10-03
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, (K131435)Ethicon Endo-Surgery, LLC2013-10-03
ANYSCAN-S SPECT IMAGING SYSTEM (K131625)Absolute Imaging Solutions2013-10-03
LEDEX (K131042)Dentmate Technology Co. , Ltd.2013-10-03
PASS LP SPINAL SYSTEM (K132575)Medicrea International2013-10-03
NATUS WARMETTE BLANKET AND DUAL CABINETS (K132110)Natus Nicolet Ireland, Ltd.2013-10-03
COLONGLIDE(R) LUBRICANT (K131617)Pediatric Pharmaceuticals, Inc.2013-10-03
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 (K132554)Aap Implantate AG2013-10-03
FINGERTIP PULSE OXIMETER (K130947)Beijing Choice Electronic Technololgy Co., Ltd.2013-10-03
CLEANSER ROOT CANAL (K130180)Cerkamed Wojciech Pawlowski2013-10-03
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT (K131673)Medtronic Sofamor Danek USA, Inc.2013-10-03
EVEREST SPINAL SYSTEM (K132361)K2m, Inc.2013-10-03
NAUTILUS SPINAL SYSTEM (K132760)Life Spine, Inc.2013-10-03
DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST (K132199)Deroyal Industries, Inc.2013-10-03
EMBOZENE MICROSPHERES (K132675)Celonova Biosciences, Inc.2013-10-03
MODIFIED FLOWGATE BALLOON GUIDE CATHETER (K131492)Concentric Medical, Inc.2013-10-03
DISPOSABLE SILICONE FOLEY CATHETER (K130908)Guangdong Baihe Medical Technology Co., Ltd.2013-10-03
BD Veritorâ„¢ System Flu A+B Assay (K132693)Becton, Dickinson and Company2013-10-02
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT (K131975)Alfa Wassermann Diagnostic Technologies, Inc.2013-10-02
FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING (K132600)Biomet Microfixation2013-10-02
PATIENT MONITOR (K123711)Shenzhen Creative Industry Co., Ltd.2013-10-01
MPACT DM LINER CONVERTER (K131458)Medacta International2013-10-01
ACCESS TOTAL BHCG (5TH IS) (K130020)Beckman Coulter, Inc.2013-10-01
TRINITY ELE (K131251)Carol Cole Company2013-10-01
TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF (K130573)Tyber Medical, LLC2013-09-30
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM (K132044)Neos Surgery S.L2013-09-30
SHASER HRS2 RX HAIR REMOVAL SYSTEM (K132266)Shaser, Inc.2013-09-30
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Every clearance here is in the API, with alerts when new ones post.