Atlas FDA

2015

3,020 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SurgiQuest AirSeal iFS System (K143404)Surgiquest, Inc.2015-03-20
LnK Anterior Cervical Plate System (K143279)L&K BIOMED Co., Ltd.2015-03-20
myVision Track Model 005 (K143211)Vital Art and Science Incorporated2015-03-20
Fetal Doppler (K142769)Icare Newlife Technologies, Inc.2015-03-20
PROXIMAL HUMERUS PLATING SYSTEM (K141493)Miami Device Solutions2015-03-20
LENSAR Laser System - fs 3D (K143010)Lensar, Inc.2015-03-20
RESTORIS POROUS PARTIAL KNEE SYSTEM (K150410)Mako Surgical Corporation2015-03-20
ONFLEX Mesh (K142711)C.R. Bard, Inc.2015-03-20
FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR (K141460)Finapres Medical Systems B.V.2015-03-20
LITe Plate System (K150449)Stryker Corp.2015-03-20
NMI PICC III and NMI PICC IV (K150448)Navilyst Medical, Inc.2015-03-19
Aquilion LB, TSX-201A/3, V6.0 (K150003)Toshibamedical Systems Corporation2015-03-19
Imbibe Aspirating XIA Taps (K143546)Stryker Corporation2015-03-19
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES (K141042)Mercator Medical (Thailand), Ltd.2015-03-19
Blackford Analysis Registration Product Family (K142337)Blackford Analysis, Ltd.2015-03-19
IS4/DF4 Port Plug (K143463)Oscor, Inc.2015-03-19
BioMonitor (K143503)Biotronik, Inc.2015-03-19
Treace Medical Concepts(TMC) Plating System (K143717)Treace Medical Concepts, Inc.2015-03-19
SYNTEC WETALI ORTHODONTIC MINI SCREWS (K142001)Syntec Scientific Corporation - Taipei Office2015-03-18
COOK HOLMIUM LASER FIBER (K133788)Cook Incorporated2015-03-18
NICAL SMART MICRO CR system for intraoral dental images (K143703)Nical Spa2015-03-18
Penumbra Smart Coil (K143218)Penumbra, Inc.2015-03-18
U-Lite (K143601)Sonoscanner Sarl2015-03-18
TULIP Natural Rubber Latex Surgeon's Glove (Powdered) (K142992)Shanghai Jinxiang Latex Products Co., Ltd.2015-03-18
PeriCoach (K143580)Analytica, Ltd.2015-03-18
DMRC Self-Cure Bracket Adhesive One Step and Primer (K142886)Danville Materials, LLC2015-03-18
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (K143651)Focus Diagnostics, Inc.2015-03-18
MiroCam Capsule Endoscope System (K143663)Intromedic Co., Ltd.2015-03-17
AmpliVue Trichomonas Assay (K143329)Quidel Corporation2015-03-17
Assurance Alar / Nasal SpO2 Sensor (K143216)Xhale, Inc.2015-03-17
Evolve UniPolar Head (K143184)Signature Orthopaedics Pty, Ltd.2015-03-17
InTone (K150180)Incontrol Medical, LLC2015-03-16
O-TWO E700,O-TWO E600,O-TWO E500 (K141595)O-Two Medical Technologies, Inc.2015-03-16
ARTEMIS LIGHT ENGINE (K141164)Quest Medical Imaging2015-03-16
NovaGold High Performance Guidewire (K150225)Neometrics, Inc.2015-03-16
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (K150030)Fukuda Denshi USA, Inc.2015-03-16
Nautilus Spinal System (K150390)Life Spine, Inc.2015-03-16
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP (K141929)Roche Diagnostics Corporation2015-03-16
Sleepware G3 (K142988)Respironics, Inc.2015-03-16
EASYDRILL AUTOSTOP CRANIAL PERFORATOR (K141455)Micromar Ind. Com. , Ltd.2015-03-16
Liquichek Maternal Serum II Control (K143379)Bio-Rad Laboratories2015-03-13
Dental Unit (K142206)Zhuhai Siger Medical Equipment Co., Ltd.2015-03-13
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) (K142877)Dutch Ophthalmic Research Center International BV2015-03-13
HOME ACCESS AIC TEST (K141944)Home Access Health Corp.2015-03-13
HARMONY LITE (K141237)Alma, Inc.2015-03-13
Progrip Laparoscopic Self-Fixating Mesh (K143386)Sofradim Production2015-03-13
NuVasive CoRoent System (K141665)Nuvasive, Inc.2015-03-13
Lapro-Clip Auto Suture Reusable Long Clip Applier (K143598)Covidien, LLC2015-03-12
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (K142766)INTEROJO, Inc.2015-03-12
Triton Canister System (K142801)Gauss Surgical, Inc.,2015-03-12
Biomet Spine Fusion System (K142634)Biomet Spine, LLC2015-03-12
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners (K142873)C.R. Bard, Inc.2015-03-12
CardiacLinx (K142352)Ross Medical Technology, Inc.2015-03-12
Bissinger Monopolar Forceps and Cables (K143662)Medagent, Inc.2015-03-12
NEURO-AUDIO (K141524)Teleemg, LLC USA2015-03-12
Attain Hybrid Guide Wire (K143316)Medtronic, Inc.2015-03-11
DRX-EVOLUTION (K141837)Carestream Health, Inc.2015-03-11
XIDF-AWS801, Angio Workstation, v5.31 (K142736)Toshibamedical Systems Corporation2015-03-11
LIAISON VZV IgG, LIAISON Control VZV IgG (K150375)DiaSorin, Inc.2015-03-11
KONUS DENTAL IMPLANT SYSTEM (K141159)Argon Med. Productions Vertriebs Gesellschaft Mbh2015-03-11
STERILIZATION POUCH/ROLL MADE WITH TYVEK (K133838)Sigma Medical Supplies Corp.2015-03-11
The MeDioStar NeXT Family (K143519)Asclepion Laser Technologies GmbH2015-03-10
Martinez Prostate Template Set (K142439)Nucletron B.V.2015-03-10
RESTORIS Multicompartmental Knee System (K150307)Mako Surgical Corp.2015-03-10
PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 (K141624)Varian Medical Systems, Inc.2015-03-10
Aquilion ONE Vision, v7.0 (K142465)Toshibamedical Systems Corporation2015-03-10
Hill-Rom Wireless Connectivity Module (K143414)Hill-Rom2015-03-10
Sense4Baby System Model B+ (MSA) (K143114)Airstrip Technologies, Inc.2015-03-10
DR Systems Zero Download 3D Viewer (Z3D) (K143318)Dr Systems, Inc.2015-03-10
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE (K142068)Medovations, Inc.2015-03-10
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio (K143753)Rayence Co., Ltd.2015-03-10
Schoelly Cystoscopes/Hysteroscopes and Accessories (K150158)Schoelly Fiberoptic GmbH2015-03-09
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls (K150275)Immunalysis Corporation2015-03-09
PACSEAL PIT & FISSURE SEALANT (K141717)Pac-Dent International, Inc.2015-03-09
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners (K142808)C.R. Bard, Inc.2015-03-09
ASAHI FUBUKI 043 / ASAHI FUBUKI (K141981)Asahi Intecc Co., Ltd.2015-03-09
ID MILLENNIUM, ID MOMENTS SILICONE (K141767)Westridge Laboratories, Inc.2015-03-09
KIMGUARD ONE-STEP Sterilization Wrap (K142782)Kimberly-Clark Health Care2015-03-09
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) (K150322)Pan Medical , Ltd.2015-03-06
Patient Examination Gloves (K143419)Hartalega NGC Sdn. Bhd.2015-03-06
PULMONE MINIBOXPFT 2.0 (K141793)Pulmone Advanced Medical Devices, Ltd.2015-03-06
X-RAY TV SYSTEM SONIALVISION G4 (K142341)Shimadzu Corp.2015-03-06
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE (DEN130046)Somna Therapeutics, LLC2015-03-06
XP300 (K143109)BTL Industries, Inc.2015-03-06
VIEWING CLIENT MOBILE (K141536)Axon Medical Technologies Corp.2015-03-06
AQANIFE (K141790)Ovesco Endoscopy AG2015-03-06
3.0T GEM RT Open Array (K143389)Ge Healthcare Coils (Usa Instruments, Inc.)2015-03-06
Sirius Starmobile tiara (K143537)Hitachi Medical Systems America, Inc.2015-03-06
Propeller System 2014-R (K142960)Reciprocal Labs2015-03-05
QuantaFlo (K143094)Semler Scientific, Inc.2015-03-05
Leva(TM) Spacer System (K150285)Spine Wave, Inc.2015-03-05
Visual-ICE Cryoablation System, Software Revision 1.3.1 (K143564)Galil Medical, Inc.2015-03-05
NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System (K143134)Cossington, Ltd.2015-03-05
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) (K143526)Thermo Fisher Scientific2015-03-05
WATERLASE IPLUS S (K141975)Biolase, Inc.2015-03-05
TraumaCad Mobile Release 1.0 (K142923)Voyant Health, Ltd.2015-03-05
AccuLIF TL and PL Cage (K143616)Stryker Corporation2015-03-05
Vitrea, Version 7.0 Medical Image Processing Software (K150258)Vital Images, Inc.2015-03-05
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS (K141655)Inova Diagnostics, Inc.2015-03-05
Affix IIS Spinous Process Plate System (K143388)Nu Vasive, Incorporated2015-03-05
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Every clearance here is in the API, with alerts when new ones post.