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
26137–26160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2018
SupaChair Powered Wheelchair
K173315 · ITI
Eurogreen International, Inc.
Physical Medicine · 117d
Cleared Feb 13, 2018
Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic...
K173535 · ODP
Titan Spine, LLC
Orthopedic · 90d
Cleared Feb 13, 2018
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM...
K173592 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Feb 13, 2018
QuickVue Influenza A+B
K180288 · PSZ
Quidel Corporation
Microbiology · 12d
Cleared Feb 12, 2018
SuRgical Planner (SRP)
K170793 · LLZ
Surgical Theater, LLC
Radiology · 333d
Cleared Feb 12, 2018
Zyston Strut Open Titanium Spacer System
K171495 · MAX
Zimmer Biomet Spine, Inc.
Orthopedic · 266d
Cleared Feb 12, 2018
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro...
K171933 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 229d
Cleared Feb 12, 2018
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · OCW
Teleflexmedical, Inc.
Gastroenterology & Urology · 151d
Cleared Feb 12, 2018
Home Use Hair Removal Device/T1, T2, T3
K172883 · OHT
Shenzhen Mareal Tech Co., Ltd.
General & Plastic Surgery · 144d
Cleared Feb 12, 2018
CASCADIA Interbody System
K172941 · OVD
K2m
Orthopedic · 139d
Cleared Feb 12, 2018
Digitex Delivery Device
K173527 · PWI
Coloplast A/S
Obstetrics & Gynecology · 90d
Cleared Feb 12, 2018
Vinyl Patient Examination Glove (Yellow)
K173561 · LYZ
Yurun Glove Co., Ltd.
General Hospital · 87d
Cleared Feb 12, 2018
Thorecon™ Fixation System
K173579 · JDQ
A & E Medical Corporation
Orthopedic · 84d
Cleared Feb 12, 2018
CELERITY 20 Steam Biological Indicator
K173634 · FRC
STERIS Corporation
General Hospital · 80d
Cleared Feb 12, 2018
CELERITY 20 Steam Incubator
K173670 · FRC
STERIS Corporation
General Hospital · 74d
Cleared Feb 12, 2018
MotoBAND CP Implant System
K173710 · HWC
Crossroads Extremity Systems, LLC
Orthopedic · 70d
Cleared Feb 12, 2018
Arthrex NanoSuture Anchor
K180118 · MBI
Arthrex, Inc.
Orthopedic · 27d
Cleared Feb 11, 2018
geko T-2 and geko Plus R-2
K180082 · IPF
Firstkind, Ltd.
Physical Medicine · 31d
Cleared Feb 10, 2018
TAV Medical Dental Implants System
K170131 · DZE
Tav Medical , Ltd.
Dental · 389d
Cleared Feb 09, 2018
BR Type Implant System
K171179 · DZE
Biotem Co., Ltd.
Dental · 291d
Cleared Feb 09, 2018
AT-6XX Series Infrared Thermometer
K171455 · FLL
Xiamen Acurio Instruments Co., Ltd.
General Hospital · 268d
Cleared Feb 09, 2018
Standard Catheter Set
K171631 · JAQ
Varian Medical Systems, Inc.
Radiology · 252d
Cleared Feb 09, 2018
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy...
K171755 · OWB
Omega Medical Imaging, LLC
Radiology · 241d
Cleared Feb 09, 2018
Southern Implants PEEK Abutments
K172160 · NHA
Southern Implants (Pty), Ltd.
Dental · 206d