Atlas FDA

2015

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
CB PROT II Posterior Spinal System (K142655)Chin Bone Technique Corp2015-01-26
NewTom 5G (K142222)Qr S.R.L.2015-01-26
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE (K142284)Alcon Laboratories, Inc.2015-01-26
KA01 Chitosan Wound Dressing (K143124)Foshan United Medical Technologies, Ltd.2015-01-26
Aviator Anterior Cervical Plate (ACP) System (K142237)Stryker Corporation2015-01-26
OMNI Interface Acetabular System (K142201)Omnlife Science2015-01-26
ZEL TIQ CoolSculpting System (K142491)Zeltiq Aesthetics, Inc.2015-01-26
Benchmark Intracranial Access System (K142321)Penumbra, Inc.2015-01-26
Trident® Tritanium® PST® Acetabular Shells (K142606)Mako Surgical Corp.2015-01-26
Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) (K143151)Bsn Medical GmbH2015-01-26
AMSEL OCCLUDER DEVICE (K140932)Amsel Medical Corporation2015-01-23
STIMULAN KIT, STIMULAN RAPID CURE (K141830)Biocomposites, Ltd.2015-01-23
OsteoSeal Bone Hemostat (K142348)Hemostasis, LLC2015-01-23
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS (K141511)Cynosure, Inc.2015-01-23
Quattro Bolt Tenodesis Screw (K143392)Cayenne Medical, Inc.2015-01-23
WOUND DRESSING WITH MANUKA HONEY (K133729)Manuka Health New Zealand , Ltd.2015-01-23
IMMULITE 2000 CEA Calibration Verification Material (K143639)Siemens Healthcare Diagnostics2015-01-23
A7 Anesthesia System (K142552)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-01-23
ELECTRODE FOR URINARY INCONTINENCE (K140265)Guangzhou Finecure Medical Equipment Co.,Ltd2015-01-23
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS (K143159)Spineguard S.A.2015-01-23
TransferMan 4m Micromanipulator (K142207)Eppendorf AG2015-01-23
Audit MicroControls Linearity LQ Cystatin-C (K143571)Aalto Scientific, Ltd.2015-01-23
RIS500 (K143000)Ray Co., Ltd.2015-01-23
Cannulated Screw System (K143460)Wrightmedicaltechnologyinc2015-01-23
STGC-LORDOTIC (K142030)Cardinal Spine, LLC2015-01-23
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K141448)Teva Medical Ltd., Migada Plant2015-01-23
MAMMAPRINT FFPE (K141142)Agendia2015-01-23
Dexcom Share Direct Secondary Displays (DEN140038)Dexcom, Inc.2015-01-23
omni TRAX Active Patient Tracker (K143396)Civco Medical Instruments CO Inc Dba Civco Medical Solutions2015-01-23
Acumed Small Fragment Base Set (K143394)Acumed, LLC2015-01-23
Visi Mobile Monitoring System (K143751)Sotera Wireless, Inc.2015-01-23
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (K133659)Philips Medical Systems2015-01-23
CAREFUSION GOLD TISSUE MARKER (K141722)Care Fusion2015-01-23
EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM (K140547)Excera Orthopedics, Inc.2015-01-22
DIGITAL ELECTROCARDIOGRAPH (K133985)Shenzhen Biocare Bio-Medical Equipment Co., Ltd.2015-01-22
EOS System (K142773)Eos Imaging2015-01-22
Sonoma Fibula Repair System (K142945)Sonoma Orthopedic Products, Inc.2015-01-22
Deltex Medical KDP72 Doppler Probe (K142932)Deltex Medical Limited2015-01-22
Mammography Color Display DP-M3010 (K143718)Canon, Inc.2015-01-22
Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) (K143247)Central Medicare Sdn Bhd2015-01-22
PODIATRY X-RAY SYSTEM (K133959)Source-Ray, Inc.2015-01-22
LEVO MAX (K140706)Levo AG2015-01-21
Myoscience iovera system (K142866)Myoscience, Inc.2015-01-21
NEUROLUMEN PN-1000 (K142025)Neurolumen, LLC2015-01-21
ECHO TRUE 3D VIEWER (K142107)Echopixel, Inc.2015-01-21
Lumenis M22 System (K142860)Lumenis, Ltd.2015-01-21
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM (K141599)Medtronic Sofamor Danek USA, Inc.2015-01-21
Everest Spinal System (K142360)K2m, Inc.2015-01-21
NANOFUSE DBM (K142104)Nanotherapeutics, Inc.2015-01-21
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm (K142678)Oticon Medical AB2015-01-21
NuVasive ALIF Buttress Plate System (K143065)Nu Vasive, Incorporated2015-01-21
Spectra Soft Tissue Biopsy Needles (K142791)Spectra Medical Devices2015-01-21
Percuvance(R) Percutaneous Surgical System (K143299)Teleflexmedical, Inc.2015-01-21
ULTRASKIN HYDROPHILIC GUIDE WIRE (K141707)Lepu Medical Technology (Beijing) Co., Ltd.2015-01-21
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System (K142572)Zimmer Dental, Inc.2015-01-21
ADVANCE Porous Coated Spiked Tibial Base (K143366)Microport Orthopedics, Inc.2015-01-21
ENDOCHOICE WATER BOTTLE CAP SYSTEM (K142155)Endochoice, Inc.2015-01-20
Synapse Occipital-Cervical-Thoracic (OCT) System (K142838)Synthes USA Products, LLC2015-01-20
MUSE System (K143634)Medigus , Ltd.2015-01-20
Zmachine (K142825)Consolidated Research of Richmond, Inc.2015-01-20
OPTIMUS CMF SYSTEM (K140037)Osteonic Co., Ltd.2015-01-20
LifeGlobal Global HP (K143498)Life Global Group, LLC2015-01-20
STERISAFE HP TABLE-TOP STEAM STERILIZER (K140736)Milton E Pedrazzi D.D.S., Inc.2015-01-20
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (K143317)Currie Medical Specialties, Inc.2015-01-20
SnapShot Fixation System (K143037)Biomet Manufacturing Corp2015-01-20
STERILUCENT STERILIZATION CONTAINER SYSTEM (K142109)Sterilucent, Inc.2015-01-20
PATIENT SPECIFIC DISTAL FEMORAL (K140898)Stanmore Implants Worldwide , Ltd.2015-01-20
Speedicath Compact Male (K143182)Coloplast A/S2015-01-20
DECISIO HEALTH PATIENT DASHBOARD (K142106)Decisio Health, Inc.2015-01-18
TruWave Disposable Pressure Transducer (K142749)Edwards Lifesciences, LLC2015-01-18
Nitinol Compression Plating System (K143023)Biomedical Enterprises, Inc.2015-01-16
P200DTx (K142897)Optos Plc.2015-01-16
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM (K141206)Edwards Lifesciences, LLC2015-01-16
Proficient (TM) Facet Screw Spine System (K142980)Spine Wave, Inc.2015-01-16
iMAR (K142584)Siemens Medical Solutions USA, Inc.2015-01-16
GUARDIAN-SG Inflatable Bone Expander System (K143006)Bm Korea Co., Ltd.2015-01-16
Audit MicroControls Linearity FD Tumor Markers II (K143573)Aalto Scientific, Ltd.2015-01-16
VICTUS FEMTOSECOND LASER PLATFORM (K141379)Technolas Perfect Vision GmbH2015-01-16
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE (K141789)Hospira, Inc.2015-01-16
GEM Flow COUPLER Device and System (K143589)Synovis Life Technologies, Inc.2015-01-16
PRECISE Trauma Nail System (K142599)Ellipse Technologies, Incorporated2015-01-16
COLLAGEN DURA MEMBRANE (K141608)Collagen Matrix, Inc.2015-01-16
All Safe Huber Safety Infusion Set (K142590)Nexus Medical, LLC2015-01-16
LaborView LV1000 (K142583)Obmedical Company2015-01-16
CrossRoads Screw System (K143039)Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015-01-16
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) (K142283)Yty Industry (Manjung) Sdn Bhd2015-01-16
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). (K142862)Careplus (M) Sdn Bhd2015-01-16
Pulse oximeter NBM-200 (K142209)Orsense, Ltd.2015-01-16
SpyGlass DS Direct Visualization System (K142922)Boston Scientific Corporation2015-01-16
ZOLL E SERIES (K133239)Zoll Medical Corporation, World Wide Headquarters2015-01-16
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (K143190)Yung Sheng Optical Co., Ltd.2015-01-16
Ultrasound Scanner System bk2300 (K143298)Bk Medical Aps2015-01-16
Arthrex Low Profile Screws (K143614)Arthrex, Inc.2015-01-16
REVOLUTION FULLFACE MASK (K140580)Respironics Inc. (Dba Philips Respironics)2015-01-16
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (K131950)Summit International Medical Technologies, Inc.2015-01-16
HIVOX SPOPAD EMS (K141921)Hivox Biotek, Inc.2015-01-16
Arthrex Fracture System (K143139)Arthrex, Inc.2015-01-16
MCS Bone Graft (K142276)Biostructures, LLC2015-01-16
VM PACS WITH VM MEDICAL WORKSTATION (K141561)Visual Medica2015-01-16
Medline ReNewal Reprocessed Compression Limb Sleeves (K143166)Surgical Instrument Service and Savings (Dba Medline Renewal2015-01-16
← Previous Next →

Track 2015 automatically

Every clearance here is in the API, with alerts when new ones post.