Atlas FDA

2013

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

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RecordFirmDate
PATHASSIST LIGHT SEEKER (K133563)Entellus Medical, Inc.2013-12-20
MULTI ANGLED ABUTMENT SYSTEM (K132067)Hiossen, Inc.2013-12-20
SOFTVUE (K123209)Delphinus Medical Technologies, Inc.2013-12-19
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM (K132086)ACON Laboratories, Inc.2013-12-19
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE (K132623)Medtronic2013-12-19
SMARTLOG DIABETES MANAGEMENT SOFTWARE (K133346)I-Sens, Inc.2013-12-19
SMARTVEST AIRWAY CLEARANCE SYSTEM (K132794)Electromed, Inc.2013-12-19
YOUNG AGAIN (K124064)Espansione Marketing S.P.A2013-12-19
PHYSOFT AMS (K130579)Physicians Software Systems, LLC2013-12-19
ELISIO-H HEMODIALYZER (K131381)Nipro Medical Corporation2013-12-19
LINA POWERBLADE PLUS (K132837)Lina Medical Aps2013-12-19
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS (K133475)Nexxt Spine, LLC2013-12-19
VAPOR CERAMIC BRACKET (K132368)Orthodontic Design and Production, Inc.2013-12-19
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) (K132952)MicroVention, Inc.2013-12-19
COMPRESSOR NEBULIZER MODEL MCN-S600XX (K123030)Dongguan Aidisy Machinery & Electronic Equipment C2013-12-19
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE (K130611)Xeridiem Medical Devices2013-12-19
LP(A) CALIBRATORS, AND LP(A) CONTROLS (K132400)Biokit, S.A.2013-12-19
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH (K133561)AngioDynamics, Inc.2013-12-19
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) (K133511)Jvckenwood Corporation2013-12-19
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 (K132418)Roche Diagnostics2013-12-18
M.U.S.T. EXTENSION (K132878)Medacta International2013-12-18
RESTLESS LEG DEVICE (DEN110009)Mary M. Sorg (An Individual) Dba PJ Sleeper'S2013-12-18
VISI MOBILE MONITIORING SYSTEM (K133586)Sotera Wireless, Inc.2013-12-18
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION (K133440)Stryker Trauma AG2013-12-18
TI STAR IMPLANT SYSTEM (K132992)T-Plus Implant Tech. Co., Ltd.2013-12-18
APTUS CANNULATED COMPRESSION SCREWS (K133460)Medartis AG2013-12-18
ALERE INFLUENZA A & B TEST (K133637)Alere Scarborough, Inc D/B/A Binax, Inc.2013-12-18
LUCO HYBRID OSA APPLIANCE (K130797)Luco Hybrid Osa Appliance, Inc.2013-12-18
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 (K132186)Optomed OY2013-12-18
SYMPHONY DEVICE (DEN110011)Sensory Medical, Inc.2013-12-18
AXIOS STENT AND DELIVERY SYSTEM (DEN130007)Xlumena, Inc.2013-12-18
ARIX HAND LOCKING SYSTEM (K132876)Jeil Medical Corporation2013-12-18
SURGEN U (K131758)Pollogen, Ltd.2013-12-18
EARLYSENSE (K131379)Earlysense, Ltd.2013-12-18
COPRA TEMP PMMA-DISK (K131664)White Peaks Dental Systems GmbH & Co. KG2013-12-18
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 (K132340)Erbe USA, Inc.2013-12-17
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS (K132996)Isoray, Inc.2013-12-17
PERFIX ILIAC SCREW SYSTEM (K132218)U&I Corporation2013-12-17
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL (K133188)Stryker Spine2013-12-17
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT (K130652)Consensus Orthopedics, Inc.2013-12-17
ST360 DEGREES SPINAL FIXATION SYSTEM (K133291)Zimmer Spine, Inc.2013-12-17
ARTHREX IBALANCE TKA SYSTEM (K133342)Arthrex, Inc.2013-12-17
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) (K133079)Alden Optical Labs., Inc.2013-12-17
ZOLL EPCR IOS (K131919)ZOLL Medical Corporation2013-12-17
OPTION ELITE VENA CAVA FILTER SYSTEM (K133243)Rex Medical, L.P.2013-12-17
ZIMMER DISTAL RADIUS PLATING SYSTEM (K133246)Zimmer, Inc.2013-12-17
PRIMADO2 TOTAL SURGICAL SYSTEM (K132264)Nakanishi, Inc.2013-12-17
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS (K130736)Helix Medical, LLC2013-12-17
2D PERFUSION (K132147)Philips Medical Systems Nederland B.V.2013-12-16
RHYTHM VIEW WORKSTATION (K133305)Topera, Inc.2013-12-16
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132522)Ethicon Endo-Surgery, LLC2013-12-16
STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY (K132785)Stryker Endoscopy2013-12-16
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS (K130073)Mikron Makina Sanayi VE Ticaret Ltd. Sti.2013-12-16
SONOSITE EDGE ULTRASOUND SYSTEM (K133454)FUJIFILM Sonosite, Inc.2013-12-16
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ (K132688)Biochemical Diagnostics, Inc.2013-12-16
CORIN MINIHIP STEM (K131986)Corin USA2013-12-16
ONETOUCH REVEAL (K132618)Lifescan, Inc.2013-12-16
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM (K132910)Synthes USA Products, LLC2013-12-16
CLEARGUARD HD END CAP (K131060)Pursuit Vascular, Inc.2013-12-16
HYALMIX CREAM (K123678)Igi Laboratories, Inc.2013-12-16
REMOVABLE PATIENT LEADS ECG CABLE (K132253)Boston Scientific2013-12-16
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES (K132240)Grandway Technology (Shenzhen) Limited2013-12-16
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY (K131792)Synthes, Inc.2013-12-16
CORIN METAFIX HIP STEM (K131952)Corin USA2013-12-16
FUSIONSYNC, CHIMAERA FUSIONSYNC (K132963)Chimaera GmbH2013-12-16
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR (DEN130022)Eneura Therapeutics2013-12-13
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS (K132015)Smith & Nephew, Inc.2013-12-13
HEPAFAT SCAN (K122035)Resonance Health Analysis Services Pty, Ltd.2013-12-13
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS (K130738)Nanjing Maidixin Medical Device Co., Ltd.2013-12-13
MICRODOSE SI (K130704)Philips Digital Mammography Sweden AB2013-12-13
PROVANT THERAPY SYSTEM (K131979)Regenesis Biomedical, Inc.2013-12-13
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM (K130913)Genesys Spine2013-12-13
CROSSCHECK PLATING SYSTEM (K132594)Solana Surgical, LLC2013-12-13
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K132484)Wrp Asia Pacific Sdn. Bhd.2013-12-13
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC (K121248)Moller Medical GmbH2013-12-13
DURABLUE STERILIZATION WRAP (K132060)Cardinal Health-Medical Products and Services2013-12-13
NORMED PELLEGRIN CALCANEUS STOP SCREW (K133035)Normed Medizin-Technik GmbH2013-12-13
BARD VENTRALEX HERNIA PATCH (K132441)C.R. Bard, Inc.2013-12-13
S-SCAN (K131996)Esaote, S.p.A.2013-12-13
MYOPERFUSION (K132523)Toshibamedical Systems Corporation2013-12-12
WTF SECURA SYRINGE AND NEEDLE (K132120)Beijing Wantefu Medical Apparatus Co., Ltd.2013-12-12
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K132862)Infopia Co, Ltd.2013-12-12
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING (K130439)Chongqing Psk Sci-Tech Development Co., Ltd.2013-12-12
PLATINUM DRF IMAGING SYSTEM (K131766)Apelem-Dms Group2013-12-12
NEOGEN PSR SYSTEM (K132754)Energist, Ltd.2013-12-12
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES (K133074)Datascope Corp.2013-12-12
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK (K132803)Medapps Inc., Dba Alere Connect2013-12-12
SYNC-RX SYSTEM (K132558)Volcano Corporation2013-12-12
MEDCOMP GEN III POWER INJECTABLE PORT (K132177)Medcomp ( Medical Components)2013-12-12
AIDI DENTAL IMPLANT SYSTEM (K123861)Aidi Biomedical, LLC2013-12-12
INQWIRE DIAGNOSTIC GUIDE WIRE (K133230)Merit Medical Systems, Inc.2013-12-12
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A (K133435)Siemens Medical Solutions USA, Inc.2013-12-12
VANGUARD XP KNEE SYSTEM (K132873)Biomet, Inc.2013-12-11
POLYSITE IMPLANTABLE INFUSION PORTS (K122834)Perouse Medical2013-12-11
WOUND MEASURING & MONITORING DEVICE (K131596)Woundvision, LLC2013-12-11
ERBE ESU MODEL VIO DV WITH ACCESSORIES (K133180)Erbe USA, Inc.2013-12-11
SIDEXIS 4 (K132773)Sirona Dental Systems GmbH2013-12-11
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM (K130317)Genesys Spine2013-12-11
ULTHERA SYSTEM (K132028)Ulthera, Inc.2013-12-11
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS (K130708)Smith & Nephew, Inc.2013-12-11
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Every clearance here is in the API, with alerts when new ones post.