FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
11041–11064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2023
Aristotle Colossus Guidewire
K222437 · MOF
Scientia Vascular, Inc.
Neurology · 167d
Cleared Jan 26, 2023
Flexible Suturing System with Anchors (FSSA)
K222589 · MBI
Integrity Orthopaedics, Inc.
Orthopedic · 153d
Cleared Jan 26, 2023
Revogene
K222779 · OOI
Meridian Bioscience, Inc.
Microbiology · 134d
Cleared Jan 26, 2023
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for...
K223415 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 77d
Cleared Jan 26, 2023
PALLAS Premium
K223588 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jan 25, 2023
PowerPAK Syringe
K220114 · MEG
Vault Paragon Group, Inc.
General Hospital · 376d
Cleared Jan 25, 2023
Advanced Bone Plate
K221150 · HRS
Double Medical Technology, Inc.
Orthopedic · 280d
Cleared Jan 25, 2023
Medline UNITE® Ankle Fusion Plating System
K222665 · HRS
Medline Industries, Inc.
Orthopedic · 141d
Cleared Jan 25, 2023
Safety Lancet
K222801 · FMK
Sarstedt AG & CO KG
General & Plastic Surgery · 131d
Cleared Jan 25, 2023
SPRINT Peripheral Nerve Stimulation (PNS) System
K223306 · NHI
Spr Therapeutics, Inc.
Neurology · 90d
Cleared Jan 25, 2023
Disposable Blood Lancets
K223314 · QRK
Huaian Hening Medical Instruments...
General & Plastic Surgery · 89d
Cleared Jan 25, 2023
OsteoCNX
K223563 · MQV
Converg Engineering
Orthopedic · 57d
Cleared Jan 25, 2023
CREED™ Cannulated Screws
K223847 · HWC
Glw, Inc.
Orthopedic · 34d
Cleared Jan 25, 2023
Carevix™ Suction Cervical Stabilizer
K223866 · HDC
Aspivix SA
Obstetrics & Gynecology · 33d
Cleared Jan 24, 2023
Xpedition ™ Powered Stair Chair (625700000000)
K222818 · ILK
Stryker Medical
Physical Medicine · 127d
Cleared Jan 24, 2023
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · GZJ
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 124d
Cleared Jan 23, 2023
Tidepool Loop
K203689 · QJI
Tidepool Project
Chemistry · 767d
Cleared Jan 23, 2023
Quality Mix Blender, Oxymixer
K221494 · BZR
Dehas Medical Systems GmbH
Anesthesiology · 245d
Cleared Jan 23, 2023
Clarius AI
K222406 · QIH
Clarius Mobile Health Corp.
Radiology · 167d
Cleared Jan 23, 2023
LigaSure™ XP Maryland Jaw Sealer/Divider
K223158 · GEI
Covidien, LLC
General & Plastic Surgery · 108d
Cleared Jan 23, 2023
Disposable Safety Lancets
K223313 · FMK
Huaian Hening Medical Instruments...
General & Plastic Surgery · 87d
Cleared Jan 23, 2023
CD Horizon Spinal System
K223494 · NKB
Medtronic
Orthopedic · 63d
Cleared Jan 22, 2023
Synthetic Polymer Glove - Polyethylene (Black)
K222531 · LZA
Ur Industry Sdn Bhd
General Hospital · 153d
Cleared Jan 21, 2023
Sentimag System
K222832 · NEU
Endomagnetics Ltd.,
General & Plastic Surgery · 123d