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
17137–17160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2021
HeRO Graft, HeRO Adapter
K203724 · DSY
Merit Medical Systems, Inc.
Cardiovascular · 155d
Cleared May 25, 2021
Tokuyama Universal Bond II
K203760 · KLE
Tokuyama Dental Corporation
Dental · 153d
Cleared May 25, 2021
LUX-Dx Insertable Cardiac Monitor
K210608 · MXD
Boston Scientific Corporation
Cardiovascular · 85d
Cleared May 25, 2021
Pathfinder Endoscope Cap
K210915 · FDS
Neptune Medical, Inc.
Gastroenterology & Urology · 57d
Cleared May 25, 2021
E-Dent 1000
K210977 · EBF
Envisiontec GmbH
Dental · 54d
Cleared May 25, 2021
AirMax Procedure Mask
K211275 · FXX
Premiumestore, LLC
General Hospital · 28d
Cleared May 25, 2021
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
K211313 · KTT
Synthes USA Products, LLC
Orthopedic · 25d
Cleared May 25, 2021
Air Relax Plus Model AR-3.0
K211460 · IRP
Diode Art Engineering Doing Business...
Physical Medicine · 14d
Cleared May 24, 2021
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
K210214 · MAX
Nu Vasive, Incorporated
Orthopedic · 117d
Cleared May 24, 2021
Catalyft PL Expandable Interbody System
K210425 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 102d
Cleared May 24, 2021
UltraLight LED System
K210535 · GEX
Rohrer Aesthetics, LLC
General & Plastic Surgery · 89d
Cleared May 24, 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K210975 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 53d
Cleared May 24, 2021
LEGION CR Porous Plus HA Femoral Components
K211246 · MBH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared May 22, 2021
Neuro-IOM system with Neuro-IOM.NET software
K190703 · GWF
Neurosoft , Ltd.
Neurology · 796d
Cleared May 21, 2021
Impla-NX (Model: ISE-270M)
K201192 · EBW
Micro-Nx Co., Ltd.
Dental · 382d
Cleared May 21, 2021
Manual Wheelchair, Model A011
K201461 · IOR
Ningbo Shenyu Medical Equipment Co.,Ltd
Physical Medicine · 353d
Cleared May 21, 2021
Ultrasonic Surgical Aspirator System
K202299 · LFL
Smtp Technology Co., Ltd.
General & Plastic Surgery · 281d
Cleared May 21, 2021
Zio Monitor
K202359 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 275d
Cleared May 21, 2021
Zio ECG Utilization Software (ZEUS) System
K202527 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared May 21, 2021
JWX-1 Plus (Navigo 16/Navigo 24)
K203806 · ITI
Yamaha Motor Co., Ltd.
Physical Medicine · 144d
Cleared May 21, 2021
IPL Hair Removal Device (Model: KCA423)
K210119 · ONF
Shenzhen Boyuan Intelligent...
General & Plastic Surgery · 122d
Cleared May 21, 2021
Neurescue device
K210358 · MJN
Neurescue Aps
Cardiovascular · 102d
Cleared May 21, 2021
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
K211273 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 24d
Cleared May 21, 2021
Universal Viewer
K211312 · LLZ
Ge Healthcare
Radiology · 21d