Atlas FDA

2014

3,202 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MAMMI (K140996)General Equipment For Medical Imaging (Oncovision-2014-06-11
MTA2.1 MATERIAL (K140955)Avalon Biomed, Inc.2014-06-11
FLEX ENDOSCOPIC INSTRUMENTS (K140662)Design Standards Corp.2014-06-11
BASE IT (K134022)Spident Co., Ltd.2014-06-11
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE (K133770)Anchor Innovation Medical (A.I.M.)2014-06-10
ESTEMP IMPLANT, ESTEMP CLEAR (K134021)Spident Co., Ltd.2014-06-10
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK (K140967)Insightra Medical2014-06-10
TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH (K140521)ArthroCare Corporation2014-06-10
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES (K140985)Thermo Fisher Scientific2014-06-10
SPIROX INEX DEVICE (K132920)Spirox, Inc.2014-06-10
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED (K141019)Fenwal, Inc.2014-06-10
MASTERSL FEMORAL STEM (K140975)Lima Corporate S.P.A.2014-06-10
HEARTNAVIGATOR RELEASE 2.0 (K140138)Philips Medical Systems Nederland B.V.2014-06-10
ORTHALIGN PLUS SYSTEM (K140331)Orthalign, Inc.2014-06-10
CHESAPEAKE SPINAL SYSTEM (K133494)K2m, Inc.2014-06-10
EMERGE EXTERNAL FIXATION SYSTEM (K140675)Emerge Medical, Inc.2014-06-10
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK (K141259)Depuy Mitek, A Johnson & Johnson Company2014-06-10
QUADROSTARPROGREEN, QUADROSTARPROYELLOW (K133297)Asclepion Laser Technologies GmbH2014-06-10
PCD 737A (K140642)Mego Afek AC , Ltd.2014-06-10
MASTERGRAFT PUTTY (K140374)Medtronic Sofamor Danek USA, Inc.2014-06-10
AIRSOFT F15 (K132901)Resmed, Ltd.2014-06-09
AERO BLUE PERFORMANCE SURGICAL GOWN (K140539)Kimberly-Clark Corporation2014-06-09
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (K140930)Convida Healthcare & Systems Corporation2014-06-09
ECLERIS SINUSCOPE (K131323)Ecleris USA2014-06-09
OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM (K140357)Orthopaedic Implant Company2014-06-09
GUARDIAN URETHRAL SHEATH (K141252)Solace Therapeutics2014-06-09
SENTIERO (K133012)Path Medical GmbH2014-06-09
DR 400 (K141192)Agfa Healthcare N.V.2014-06-06
EEVA 2.0 (DEN120015)Auxogyn, Inc.2014-06-06
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE (K132415)Teleflexmedical, Inc.2014-06-06
BIOMONITOR (K132960)Biotronik, Inc.2014-06-06
CA 125 II CALSET II (K140112)Roche Diagnostics2014-06-06
STARBAND AND STARLIGHT (K140353)Orthomerica Products, Inc.2014-06-06
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING (K140972)Medtronic, Inc.2014-06-06
ENSITE VELOCITY SYSTEM (K141050)St Jude Medical2014-06-06
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (K140546)Healgen Scientific,, LLC2014-06-06
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM (K141185)Boston Scientific Corp2014-06-06
AXERA 2 ACCESS SYSTEM (K140871)Arstasis, Inc.2014-06-06
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM (K132205)Inova Labs, Inc.2014-06-06
HANDHELD MONITOR (K131762)Guangdong Biolight Meditech Co., Ltd.2014-06-06
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT (K141060)On-X Life Technologies, Inc.2014-06-06
ATOVEN (K133774)Bio-Med USA, Inc.2014-06-06
ALADDIN (K131567)Visia Imaging S.R.L.2014-06-05
U FIT DENTAL IMPLANT SYSTEM (K132956)T Strong, Inc.2014-06-05
ENDOWRIST VESSEL SEALER (K140189)Intuitive Surgical, Inc.2014-06-05
LOGIQ S7 EXPERT, LOGIQ S7 PRO (K141261)GE Healthcare2014-06-05
RSP HUMERAL SOCKET INSERT (K141006)Djo Global2014-06-05
BN LUMBAR CAGE SYSTEM (K140564)Medyssey USA, Inc.2014-06-05
HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM (K140422)Het Systems, LLC2014-06-05
FLASH PENTA MB QUICK, FLASH MB QUICK (K140602)3M Espe AG2014-06-05
STRYKER KWIC NEEDLE (K140868)Orthovita, Inc.2014-06-05
MEDICAD CLASSIC (K140434)Hectec GmbH2014-06-05
COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH (K140481)Colgate-Palmolive Company2014-06-05
STARCERAM (K140924)H.C. Starck Ceramics GmbH2014-06-05
EXHALATION VALVE (K132143)Intersurgical Incorporated2014-06-04
MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) (K123126)Shanghai Motex Healthcare Co., Ltd.2014-06-04
ZIBONE CERAMIC DENTAL IMPLANT SYSTEM (K132585)Coho Technology Co., Ltd.2014-06-04
SOFTECH PLUS ETC02 CANNULA (K132946)Teleflexmedical, Inc.2014-06-04
STERISPINE PS (K140802)Safe Orthopaedics2014-06-04
PANPAC INFLATABLE DOCUT PESSARY (K132670)Panpac Medical Corporation2014-06-04
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) (K133850)Prismatik Dentalcraft, Inc.2014-06-04
VTI SUCTION IRRIGATION SYSTEM (K141323)Regulatory Technology Services, LLC2014-06-04
ASTRAL VENTILATOR (K133868)Resmed, Ltd.2014-06-04
MED-RX ORAL/ENTERAL SYRINGE (K131183)Benlan, Inc.2014-06-03
BIOMET CANNULATED SCREW SYSTEM (K140891)Biomet, Inc.2014-06-03
OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5 (K140226)Science For Biomaterials2014-06-03
0180 INTUITION, 0072 PRECISION (K140683)Arcoma AB2014-06-03
SMR TT METAL BACK GLENOID (K133349)Lima Corporate S.P.A.2014-06-03
AXON-BUS PROSTHETIC SYSTEM (K123795)Otto Bock Austria2014-06-03
RANGE SPINAL SYSTEM (K141147)K2m, Inc.2014-06-03
EWNL SAFETY SYRINGE WITH NEEDLE (K132557)Jiamei-Un Co., Ltd.2014-06-03
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (K140026)Lacrimedics, Inc.2014-06-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) (K140468)Becton, Dickinson and Company2014-06-02
COMPRESSYN STAPLE (K140358)Dallen Medical, Inc.2014-06-02
BRIGHTMATTER PLANNING SOFTWARE (K140337)Synaptive Medical, Inc.2014-06-02
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR (K140774)Terumo Cardiovascular Systems Corporation2014-06-02
POWDER FREE POLYETHYLENE EXAMINATION GLOVES (K133478)Shijiazhuang Hongzan Plastic Technology Co.,Ltd2014-06-02
ASPIRON ACP SYSTEM (K140234)U&I Corp.2014-06-02
LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM (K132016)Texas Applied Biomedical Services, Inc.2014-06-02
ARIA WIFI SMART SCALE (K133872)Fitbit, Inc.2014-06-02
SCHOELLY ARTHROSCOPE (K133682)Scholly Fiberoptic GmbH2014-06-02
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE (K140364)Chison Medical Imaging Co., Ltd.2014-06-02
CHOCOLATE PTCA BOLLOON CATHETER (K133633)Trireme Medical, Inc.2014-06-02
VIRAGE OCT SPINAL FIXATION SYSTEM (K133556)Zimmer Spine, Inc.2014-06-02
PLS (POSTERIOR LUMBAR SYSTEM) (K140787)Sintea Plustek, LLC2014-05-30
PROFEMUR TL CLASSIC LONG NECK HIP STEMS (K140676)Microport Orthopedics, Inc.2014-05-30
A-TONE IPL SYSTEM (K131712)Ybk Investment, Inc.2014-05-30
X-MIND UNITY (K132378)De Gotzen S.R.L.2014-05-30
SURFLASH SAFETY I.V. CATHETER (K141138)Kofu Factory of Terumo Corp.2014-05-30
NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F (K133123)Yty Industry (Manjung) Sdn Bhd2014-05-30
T1/T2/T3 TURBINE FAMILY (K131319)Sirona Dental Systems GmbH2014-05-30
OPTOSSOL COMPRESSION DEVICE SYSTEM (K140875)Genossis, LLC2014-05-30
LMA FAMILY OF AIRWAYS (K130304)The Laryngeal Mask Co., Ltd.2014-05-30
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT (K141124)Vascular Flow Technologies, Ltd.2014-05-30
BODY FAT ANALYZER AND SCALE (K140594)Conmo Electronic Company Limited2014-05-30
ULTRASOUND SCANNER SYSTEM BK2300 (K140428)B-K Medical Aps2014-05-30
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K140559)Sechrist Industries, Inc.2014-05-30
ULTRASONIC MESH NEBULIZER (K140211)Foshan Gaunying Electronics Co., Ltd.2014-05-30
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE (K123940)Demetech Corp.2014-05-30
AERO-AL LUMBAR CAGE SYSTEM (K133328)Stryker Corporation2014-05-30
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