Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ARCHIMED REMEDY CERVICAL PLATE (K100215)Archimed, Inc.2010-04-07
HARMONIC FOCUS SHEARS (K100597)Ethicon Endo-Surgery, LLC2010-04-07
PROVANT SYSTEM, MODEL 4201 (K091791)Regenesis Biomedical, Inc.2010-04-07
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM (K093243)Coagusense, Inc.2010-04-07
FEMVUE CORNUAL BALLOON CATHETER (K100662)Femasys, Inc.2010-04-07
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 (K093845)ETHICON, Inc.2010-04-07
ESTECH COBRA BIPOLSR II (K100224)Endoscopic Technologies, Inc. D/B/A Estech2010-04-07
LANX ANTERIOR PLATING SYSTEM (K092765)Lanx, Inc.2010-04-07
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 (K092984)Panpac Medical Corporation2010-04-07
DIGITAL SPOT MAMMOGRAPHY SYSTEM (K100692)Hologic, Inc.2010-04-06
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 (K100673)Medica Corp.2010-04-06
MERCURY MEDICAL T-PIECE RESUSCITATOR (K093913)Mercury Medical, Inc.2010-04-06
MED-LOK (K093176)Sta-Med, LLC2010-04-06
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100419)Tangshan Yongkang Glove Co., Ltd.2010-04-06
VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR (K091770)Shijiazhuang Huijingyuan Plastic Co, Ltd.2010-04-06
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR (K093935)Smith & Nephew, Inc.2010-04-05
MODEL DGH 6000 SCANMATE A (K093371)Dgh Technology, Inc.2010-04-05
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM (K100599)Orthosoft, Inc.2010-04-05
MINIHIP STEM (K083312)Corin USA2010-04-05
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM (K100023)Medtox Diagnostics, Inc.2010-04-05
MR INSPIRE WITH EXTENDED KIT (K100164)Paramed S.R.L.2010-04-05
SIMONDR DRP (K093790)Simondr, Inc.2010-04-05
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE (K093632)Drager Medical AG & Co. Kgaa2010-04-05
LIFEGLOBAL PROTEIN SUPPLEMENT (K092578)Genx Intl., Inc.2010-04-05
CENTURY MODEL 105C (K093341)Sybron Dental Specialties, Inc.2010-04-05
S-SCAN, MODEL 9800020010 (K100670)Esaote, S.p.A.2010-04-05
SYSTEM 1.5 STERILE PROCESSING SYSTEM (K090036)STERIS Corporation2010-04-05
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM (K092387)Minntech Corp.2010-04-05
COBAS U411 TEST SYSTEM (K093555)Roche Diagnostics2010-04-02
HELIOX LOW FLOW SENTRY BLENDER (K092484)Cardinal Health 207, Inc.2010-04-02
ENHANCED ULTRA VIT PROBE (K093305)Alcon Research, Ltd.2010-04-02
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY (K091716)Merits Health Products Co., Ltd.2010-04-02
PROXISCAN MODEL 101 (K093706)Hybridyne Imaging Technologies, Inc.2010-04-02
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V (K100230)Eleme Medical, Inc.2010-04-02
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 (K093333)Primus Sterilizer Company, LLC2010-04-02
ALEXIS ORTHOPAEDIC WOUND RETRACTOR (K100120)Applied Medical Resources Corp.2010-04-02
SPRYTIE, MODELS ST001, ST002 AND ST003 (K092530)Russell B. Walther2010-04-02
AEGIS & AEGIS II SPINAL SYSTEM (K092076)Corentec Co., Ltd.2010-04-02
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 (K091933)Inno-Health Technology, Inc.2010-04-02
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A (K093858)St. Jude Medical, Cardiac Rhythm Management Divisi2010-04-02
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 (K092481)New Aqua, LLC (Dba Aqua Systems)2010-04-02
STRYKER SONICPIN SYSTEM (K091955)Howmedica Osteonics Corp.2010-04-02
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE (K093135)Venner Medical (Singapore) Pte, Ltd.2010-04-02
INTRAUTERINE INSEMINATION (IUI) CATHETER (K092579)Fertiligent, Ltd.2010-04-02
VITALA CONTINENCE CONTROL DEVICE (K083785)Convatec2010-04-02
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 (K092785)Vasomedical, Inc.2010-04-02
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM (K093321)BioHorizons Implant Systems, Inc.2010-04-02
MACH LED SC (K093009)Dr. Mach GmbH & Co. KG2010-04-01
CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 (K093506)Taidoc Technology Corporation2010-04-01
PADCHECK (K093205)Padtest, LLC2010-04-01
1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 (K093400)Unilife Medical Solutions Limited2010-04-01
SE-601 SERIES ELECTROCARDIOGRAPH (K093869)Edan Instruments, Inc.2010-04-01
ELECSYS TROPONIN I CALCHECK 5 (K100594)Roche Diagnostics2010-04-01
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 (K100633)D B Orthodontics, Ltd.2010-04-01
MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED (K092391)Concord Medical Products2010-04-01
MACH LED MC (K093010)Dr. Mach GmbH & Co. KG2010-04-01
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR (K093844)Smith & Nephew, Inc.2010-04-01
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM (K100575)Ldr Spine USA2010-03-31
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US (K100314)Medacta International S.A.2010-03-31
HANDHELD ECG MONITOR, MODEL MD100 (K093872)Beijing Choice Electronic Technololgy Co., Ltd.2010-03-31
ARSTASIS ACCESS SYSTEM (K100615)Arstasis, Inc.2010-03-30
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER (K092849)Epocal, Inc.2010-03-30
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM (K100401)Hu-Friedy Mfg. Co., Inc.2010-03-30
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 (K092448)Hivox Biotek, Inc.2010-03-30
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (K100671)Novabone Products, LLC2010-03-30
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE (K093633)Draegerwerk AG & CO Kgaa2010-03-30
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM (K100559)Interlace Medical, Inc.2010-03-30
VITAL SIGNS MONITOR (K093016)Shenzhen Creative Industry Co., Ltd.2010-03-30
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM (K093494)Pathfinder Therapeutics, Inc.2010-03-30
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K100712)Boston Scientific Corporation2010-03-30
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) (K100641)Relievant Medsystems2010-03-30
SYSMEX MODEL XT-4000I (K091313)Sysmex America, Inc.2010-03-30
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES (K093928)Synthes (Usa)2010-03-29
STAIR SYSTEMS PACS & DICOM VIEWER (K100236)Stair Systems, Inc.2010-03-29
SYNTHES STERNAL FIXATION SYSTEM (K093772)Synthes2010-03-29
BIOPLEX 2200 MMRV IGG (K091616)Bio-Rad Laboratories2010-03-29
ARTISAN AESTHETIC SYSTEM (K100270)Palomar Medical Technologies, Inc.2010-03-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100337)Tangshan Qixin Glove Co., Ltd.2010-03-29
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK (K100555)Omni Life Science, Inc.2010-03-29
ELECSYS CK-MB CALCHECK 5 (K093582)Roche Diagnostics2010-03-29
TELAVANCIN 30 UG, BBL SENSI-DISC (K100722)Becton, Dickinson and Company2010-03-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100324)Tangshan Hengtong Plastic Products Co.2010-03-29
GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM (K092493)Gpc Medical, Ltd.2010-03-29
CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 (K093941)Taidoc Technology Corporation2010-03-26
G-FORCE TI SUTURE ANCHOR SYSTEM (K100579)Wrightmedicaltechnologyinc2010-03-26
MOVES (K093261)Thornhill Research, Inc.2010-03-26
HOVEROUND TEKNIQUE, MODEL HD-6 (K100527)Hoveround Corp.2010-03-26
TORQMAX SHEATH GRIP ACCESSORY (K093257)Spectranetics Corp.2010-03-26
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION (K091940)Tonica Elektronik A/S2010-03-26
INDUS ANTERIOR CERVICAL PLATE SYSTEM (K093776)Spinefrontier, Inc.2010-03-26
INFILTRATION KIT (K100062)Dmg USA, Inc.2010-03-26
FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 (K092061)Genexel Medical Instrument, Inc.2010-03-26
PIVIT A/B ST AND PIVIT A/B ST-R (K093524)Tyrx, Inc.2010-03-26
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 (K091538)Wet Nose Technologies, LLC2010-03-25
CERAMIR CROWN & BRIDGE (K100510)Doxa AB2010-03-25
ETHICON ENDO SURGERY SLOTTED ANOSCOPE (K093896)Ethicon Endo-Surgery, Inc.2010-03-25
RAISIN PERSONAL MONITOR (K093976)Proteus Biomedical, Inc.2010-03-25
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 (K093406)AngioDynamics, Inc.2010-03-25
DBB-06 HEMODIALYSIS DELIVERY SYSTEM (K091978)NIKKISO CO., LTD.2010-03-25
CODMAN STERILIZATION CONTAINERS (K092437)Codman & Shurtleff, Inc.2010-03-25
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