FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13465–13488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2022
Paltop Conical Implant System
K220200 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 121d
Cleared May 25, 2022
KardiaMobile 6L
K220350 · DXH
AliveCor, Inc.
Cardiovascular · 107d
Cleared May 25, 2022
SwiftMR
K220416 · LLZ
Airs Medical, Inc.
Radiology · 100d
Cleared May 25, 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
K220481 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 96d
Cleared May 25, 2022
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
K220578 · GZJ
Bozhou Rongjian Medical Appliance...
Neurology · 86d
Cleared May 25, 2022
InnoVoyce Laser Fiber
K220793 · GEX
Innovoyce, LLC
General & Plastic Surgery · 68d
Cleared May 25, 2022
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated...
K221180 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 25, 2022
CD Horizon™ Spinal System
K221244 · NKB
Medtronic
Orthopedic · 23d
Cleared May 24, 2022
BENCOX Mirabo Z Cup Cortinium
K210614 · LPH
Corentec Co., Ltd.
Orthopedic · 449d
Cleared May 24, 2022
M-Vizion Monobloc
K212327 · LZO
Medacta International S.A.
Orthopedic · 301d
Cleared May 24, 2022
S-Line
K213191 · LGZ
Barkey GmbH & Co. KG
General Hospital · 237d
Cleared May 24, 2022
Medline General Surgery Tray
K213481 · LRO
Medline Industries, Inc.
General & Plastic Surgery · 207d
Cleared May 24, 2022
LigaPASS™ 2.0 Ligament Augmentation System
K213659 · OWI
Medicrea International SA
Orthopedic · 186d
Cleared May 24, 2022
Disposable Face Mask
K220191 · FXX
Jiujiang Taixin Technology Co., Ltd.
General Hospital · 120d
Cleared May 24, 2022
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
K220888 · QSR
Medacta International S.A.
Orthopedic · 57d
Cleared May 24, 2022
MY01 Continuous Compartmental Pressure Monitor
K220952 · LXC
MY01, Inc.
Orthopedic · 53d
Cleared May 24, 2022
e-motion M25
K221215 · ITI
Alber GmbH
Physical Medicine · 27d
Cleared May 23, 2022
Assure Titanium Blood Glucose Monitoring System
K200788 · PZI
Arkray, Inc.
Chemistry · 788d
Cleared May 23, 2022
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with...
K211810 · LZA
Pt. Shamrock Manufacturing Corpora
General Hospital · 346d
Cleared May 23, 2022
LiquiBand XL
K211878 · OMD
Advanced Medical Solutions Limited
General & Plastic Surgery · 336d
Cleared May 23, 2022
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical...
K212563 · KIF
Prevest Denpro Limited
Dental · 283d
Cleared May 23, 2022
DailyMate Orthodontic Aligner System
K212803 · NXC
3D Global Biotech, Inc.
Dental · 263d
Cleared May 23, 2022
ONO Retrieval Device
K212988 · MMX
Onocor Vascular, LLC
Cardiovascular · 245d
Cleared May 23, 2022
Triever24, Triever20
K213402 · QEW
Inari Medical
Cardiovascular · 217d