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

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175,820 results
29833–29856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2017
Medtronic Transportation/Sterilization Cassettes
K163279 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 94d
Cleared Feb 23, 2017
TZ SKULL PIN Adult
K163322 · HBL
Tz Medical, Inc.
Neurology · 90d
Cleared Feb 23, 2017
Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
K163688 · IYN
Medisono, LLC
Radiology · 57d
Cleared Feb 23, 2017
ImPACT
K170209 · POM
Impact Applications, Inc.
Neurology · 30d
Cleared Feb 23, 2017
Truliant Femoral Components
K170240 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 23, 2017
GRAVITYTM PEEK-OPTIMA Suture Anchor
K170265 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Feb 22, 2017
BEMER Classic Set, BEMER Pro-Set
K151834 · NGX
Bemer Int AG
Physical Medicine · 597d
Cleared Feb 22, 2017
SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers,...
K152022 · MAX
Globus Medical, Inc.
Orthopedic · 582d
Cleared Feb 22, 2017
MEG-TORQ
K161500 · EKX
Micro-Nx Co., Ltd.
Dental · 266d
Cleared Feb 22, 2017
EasyOne Pro Respiratory Analysis System
K161534 · BTY
Ndd Medizintechnik AG
Anesthesiology · 264d
Cleared Feb 22, 2017
ND YAG Q-switch Laser Therapy Machine
K161926 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 224d
Cleared Feb 22, 2017
PROPHECY INVISION Preoperative Navigation Alignment System
K162795 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 141d
Cleared Feb 22, 2017
BLUEPRINT Patient Specific Instrumentation
K162800 · KWS
Tornier S.A.S.
Orthopedic · 140d
Cleared Feb 22, 2017
Sofia RSV FIA on Sofia 2 analyzer
K162911 · GQG
Quidel Corporation
Microbiology · 128d
Cleared Feb 22, 2017
Stryker Navigation System with CranialMap software application, Stryker...
K162929 · HAW
Stryker Corporation
Neurology · 126d
Cleared Feb 22, 2017
Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
K163041 · LZA
Pt. Medisafe Technologies
General Hospital · 114d
Cleared Feb 22, 2017
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue,...
K163126 · LZA
Blue Sail Medical Co.,Ltd
General Hospital · 106d
Cleared Feb 22, 2017
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
K163298 · JWY
Liofilchem S. R. L.
Microbiology · 92d
Cleared Feb 22, 2017
my Patch sl
K163535 · DSH
Dms-Service, LLC
Cardiovascular · 68d
Cleared Feb 22, 2017
HS70A Diagnostic Ultrasound System
K163691 · IYN
Samsung Medison Co., Ltd.
Radiology · 56d
Cleared Feb 22, 2017
Aquarius 8600
K170202 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 30d
Cleared Feb 21, 2017
SMR TT Metal Back Glenoid, Bone Graft instruments
K161120 · PHX
Lima Corporate S.P.A.
Orthopedic · 306d
Cleared Feb 21, 2017
SurgTech Trauma System
K161894 · HWC
Surgtech, Inc.
Orthopedic · 225d
Cleared Feb 21, 2017
UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System -...
K161987 · DZE
Dio Corporation
Dental · 217d