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
19177–19200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2020
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
K201829 · KGO
Medline Industries, Inc.
General Hospital · 69d
Cleared Sep 09, 2020
AcroDTI Visualizer
K201948 · LLZ
Acroviz, Inc.
Radiology · 58d
Cleared Sep 09, 2020
Responsive Arthroscopy Suture Anchor System
K202153 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 37d
Cleared Sep 09, 2020
3Shape Implant Studio
K202256 · LLZ
3Shape Medical A/S
Radiology · 30d
Cleared CT Sep 08, 2020
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K201194 · HQD
Acuity Polymers, Inc.
Ophthalmic · 127d
Cleared Sep 08, 2020
Disposable Medical Face Mask
K201470 · FXX
Jkh USA, LLC
General Hospital · 97d
Cleared Sep 08, 2020
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
K202014 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Sep 08, 2020
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair...
K202252 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Sep 08, 2020
CD Horizon Spinal System
K202328 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 22d
Cleared Sep 08, 2020
Surgical Mask-Model Number CW01
K202354 · FXX
Hunan Heng Chang Pharmaceutical Co.,...
General Hospital · 20d
Cleared Sep 06, 2020
EyeBOX
K201841 · QEA
Oculogica, Inc.
Neurology · 66d
Cleared Sep 04, 2020
NICU V'02
K190561 · BZL
Cosmed Nordic Aps
Anesthesiology · 549d
Cleared Sep 04, 2020
Lumipulse G CA15-3
K192524 · MOI
Fujirebio Diagnostics,Inc.
Immunology · 357d
Cleared Sep 04, 2020
BD Syringe NRFit Lok and BD Syringe NRFit Slip
K192538 · QEH
Becton, Dickinson and Company
General Hospital · 354d
Cleared Sep 04, 2020
iCTmotor (WL-1)
K193341 · EBW
Dentium Co., Ltd.
Dental · 276d
Cleared Sep 04, 2020
MEBO Wound Dressing
K193439 · FRO
Mebo Life Science, Inc.
General & Plastic Surgery · 268d
Cleared Sep 04, 2020
MSLS6QF TENS/PMS Device
K193655 · NUH
Self Doctor Care, LLC
Neurology · 249d
Cleared Sep 04, 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
K200835 · FRO
3M Company
General & Plastic Surgery · 157d
Cleared Sep 04, 2020
Arthrex NanoScope System
K201134 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 129d
Cleared Sep 04, 2020
Neodent Implant System - GM Helix Implants 7.0
K201225 · DZE
Jjgc Industria E Comercio DE...
Dental · 121d
Cleared Sep 04, 2020
Plain Surgical Mask
K201517 · FXX
Aok Tooling Limited
General Hospital · 88d
Cleared Sep 04, 2020
Protective Face Mask for Medical Use
K201537 · FXX
Shandong Shengquan New Material Co.,...
General Hospital · 88d
Cleared Sep 04, 2020
TruLift Expandable Spacer System
K201721 · MAX
Life Spine, Inc.
Orthopedic · 73d
Cleared Sep 04, 2020
Astopad Patient Warming System
K202197 · DWJ
Stihler Electronic GmbH
Cardiovascular · 30d