Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
34561–34584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2015
Monster Screw System
K151418 · HWC
Paragon 28
Orthopedic · 48d
Cleared Jul 15, 2015
AT235
K151616 · ETY
Interacoustics A/S
Ear, Nose, Throat · 30d
Cleared Jul 15, 2015
St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology...
K151622 · DRF
St Jude Medical
Cardiovascular · 29d
Cleared Jul 15, 2015
LnK Cervical Interbody Fusion Cage System
K151677 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 23d
Cleared Jul 14, 2015
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with...
K142190 · KGO
Pt. Medisafe Technologies
General Hospital · 340d
Cleared Jul 14, 2015
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green,...
K142398 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 321d
Cleared Jul 14, 2015
Rapid Hair Removal Pads
K150349 · LDD
Full Power Aed
Cardiovascular · 153d
Cleared Jul 14, 2015
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula,...
K150844 · JOH
Covidien
Anesthesiology · 106d
Cleared Jul 14, 2015
Pyrenees Cervical Plate System
K150983 · KWQ
K2m
Orthopedic · 91d
Cleared Jul 14, 2015
InFill Interbody Fusion Devices
K151184 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 71d
Cleared Jul 14, 2015
Nautilus Spinal System
K151196 · NKB
Life Spine, Inc.
Orthopedic · 70d
Cleared Jul 14, 2015
Microlife Wrist Watch Blood Pressure Monitor
K151330 · DXN
Microlife Intellectual Property GmbH,...
Cardiovascular · 56d
Cleared Jul 13, 2015
Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and...
K150084 · PIF
Covidien
Gastroenterology & Urology · 179d
Cleared Jul 13, 2015
EVOS Lumbar Interbody System
K150321 · MAX
Cutting Edge Spine, LLC
Orthopedic · 154d
Cleared Jul 13, 2015
Neodent Implant System
K150367 · NHA
Jjgc Industria E Comercio DE...
Dental · 151d
Cleared Jul 13, 2015
ArgenZ Esthetic Plus
K150919 · EIH
The Argen Corporation
Dental · 98d
Cleared Jul 13, 2015
Aura DR 43C-AG flat panel detector
K151014 · MQB
Abyzr Co., Ltd.
Radiology · 88d
Cleared Jul 13, 2015
Vitrea Software Toshiba Package, VSTP-001A
K151091 · LLZ
Toshibamedical Systems Corporation
Radiology · 81d
Cleared Jul 11, 2015
Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation...
K142468 · DSH
Cardiac Insight, Inc.
Cardiovascular · 311d
Cleared Jul 10, 2015
SpineFab Vertebral Body Replacement (VBR) System
K142005 · MQP
Oxford Performance Materials
Orthopedic · 352d
Cleared Jul 10, 2015
INOmax DSIR Plus MRI
K143213 · MRN
Ino Therapeutics/Ikaria
Anesthesiology · 242d
Cleared Jul 10, 2015
IOLMaster700
K143275 · HJO
Carl Zeiss Meditec, Inc.
Ophthalmic · 238d
Cleared Jul 10, 2015
SIGNA Pioneer
K143345 · LNH
Ge Healthcare Japan Corporation
Radiology · 231d
Cleared Jul 10, 2015
The Simple Locking IntraMedullary (SLIM) System
K143355 · HSB
Pega Medical, Inc.
Orthopedic · 228d