FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cleared only ×
175,820 results
18049–18072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2021
BioPoly Great Toe Hemiarthroplasty Implant
K203634 · KWD
BioPoly, LLC
Orthopedic · 53d
Cleared Feb 02, 2021
EzRay M (Model: VMX-P300)
K203667 · IZL
VATECH Co., Ltd.
Radiology · 48d
Cleared Feb 01, 2021
FAST-FIX FLEX
K203393 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d
Cleared Feb 01, 2021
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K203483 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 66d
Cleared Feb 01, 2021
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
K203537 · KPR
Sedecal., Sa.
Radiology · 60d
Cleared Feb 01, 2021
Hoffmann LRF System
K203568 · KTT
Stryker GmbH
Orthopedic · 56d
Cleared Feb 01, 2021
Monopolar Hook
K203603 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 54d
Cleared Feb 01, 2021
HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
K203794 · MBI
Medos International SARL
Orthopedic · 35d
Cleared Jan 29, 2021
EndoClot
K190677 · QAU
Endoclot Plus Co., Ltd.
General & Plastic Surgery · 686d
Cleared Jan 29, 2021
DEX Device
K191878 · GEI
Dex Surgical
General & Plastic Surgery · 564d
Cleared Jan 29, 2021
i_Space 1.5T Superconducting Magnetic Resonance Imaging System
K192650 · LNH
Mri Division,Beijing Wandong Medical...
Radiology · 493d
Cleared Jan 29, 2021
BEE Cages
K200429 · ODP
NGMedical GmbH
Orthopedic · 343d
Cleared Jan 29, 2021
Visage Breast Density
K201411 · QIH
Visage Imaging GmbH
Radiology · 246d
Cleared Jan 29, 2021
Sunset Heated CPAP Tube
K201418 · BZE
Sunset Healthcare Solutions, Inc.
Anesthesiology · 245d
Cleared Jan 29, 2021
Luna® G3 BPAP 25A
K201620 · BZD
3B Medical, Inc.
Anesthesiology · 228d
Cleared Jan 29, 2021
Disposable Pre-calibrated Suction
K201752 · HAW
Brainlab AG
Neurology · 217d
Cleared Jan 29, 2021
Rapid Acoustic Pulse Device
K201801 · GEX
Soliton, Inc.
General & Plastic Surgery · 213d
Cleared Jan 29, 2021
PediFlex Flexible Nail System
K201838 · HTY
OrthoPediatrics Corp.
Orthopedic · 211d
Cleared Jan 29, 2021
E-connect S Endo Motor with built-in Apex Locator
K201993 · EKX
Changzhou Sifary Medical Technology...
Dental · 196d
Cleared Jan 29, 2021
VX650
K202221 · HKI
Luneau Technology Operations
Ophthalmic · 176d
Cleared Jan 29, 2021
Neodent Implant System - Zirconia Implant System
K202282 · NHA
Jjgc Industria E Comercio DE...
Dental · 170d
Cleared Jan 29, 2021
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation...
K202310 · FYC
Wildcat Ppe, LLC
General Hospital · 168d
Cleared Jan 29, 2021
Protective Face Mask for Medical Use
K202358 · FXX
Hunan Heng Chang Pharmaceutical Co.,...
General Hospital · 163d
Cleared Jan 29, 2021
MAGIC Infusion Catheter
K202366 · KRA
Balt USA, LLC
Neurology · 163d