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
17185–17208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2021
Ohlendorf Clear Aligner
K210540 · NXC
Ohlendorf Appliance Laboratory
Dental · 84d
Cleared May 19, 2021
Steam-Dot Process Indicator
K210553 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 83d
Cleared May 19, 2021
Vereos PET/CT
K210880 · KPS
Philips Medical Systems Nederland B.V.
Radiology · 56d
Cleared May 18, 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423 · JWY
Beckman Coulter, Inc.
Microbiology · 266d
Cleared May 18, 2021
BonOs Inject, Pedicle screw kits, Cement pusher
K202458 · LOD
Osartis GmbH
Orthopedic · 264d
Cleared May 18, 2021
Personal Lubricant Jelly
K202667 · NUC
Nantong Health & Beyond Hygienic...
Obstetrics & Gynecology · 246d
Cleared May 18, 2021
Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
K202709 · GDW
Ningbo Verykind Medical Device Co., Ltd.
General & Plastic Surgery · 244d
Cleared May 18, 2021
True Tulip, True M.I.S.
K210816 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 61d
Cleared May 18, 2021
Persona Revision Knee System Femoral Metaphyseal Cones
K210829 · JWH
Zimmer, Inc.
Orthopedic · 60d
Cleared May 17, 2021
Cercare Medical Neurosuite
K202793 · LLZ
Cercare Medical Aps
Radiology · 237d
Cleared May 17, 2021
Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer...
K203682 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 151d
Cleared May 17, 2021
Needleless Connector
K210217 · FPA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 110d
Cleared May 17, 2021
NitriTec Vinyl Glove Powder Free Blue
K210460 · LYZ
Zhonghong Pulin Medical Products Co.,...
General Hospital · 90d
Cleared May 17, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K211037 · LNH
Canon Medical Systems Corporation
Radiology · 40d
Cleared May 17, 2021
Ear-Friendly Mask
K211105 · FXX
Ray Co., Ltd.
General Hospital · 34d
Cleared May 14, 2021
BoneTrust Mini Implant System
K200573 · DZE
Medical Instinct Deutschland GmbH
Dental · 435d
Cleared May 14, 2021
Cardiac Trigger Monitor
K202138 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 287d
Cleared May 14, 2021
Klarity Bolus
K202747 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 235d
Cleared May 14, 2021
Gx-IVF, Gx-TL, Gx-MOPS PLUS
K202862 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 228d
Cleared May 14, 2021
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O...
K203226 · GCM
Richard Wolf Medical Instruments...
General & Plastic Surgery · 193d
Cleared May 14, 2021
HOLOSCOPE-i
K210072 · LLZ
Real View Imaging , Ltd.
Radiology · 123d
Cleared May 14, 2021
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle....
K210200 · FMF
Set Medikal Sanayi VE Ticaret Anonim...
General Hospital · 109d
Cleared May 14, 2021
Disposable Medical mask
K210302 · FXX
Anhui Jbh Medical Apparatus Co., Ltd.
General Hospital · 100d
Cleared May 14, 2021
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
K210417 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 92d