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
27817–27840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2017
Accutorr 7/VS-900 Vital Signs Monitor
K170712 · MWI
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 146d
Cleared Aug 02, 2017
Hearing Healthcare Pro
K171038 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 118d
Cleared Aug 02, 2017
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
K171172 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 103d
Cleared Aug 02, 2017
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K171595 · OUR
Medacta International S.A.
Orthopedic · 63d
Cleared Aug 02, 2017
AUTOCON III 400
K171717 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 54d
Cleared Aug 02, 2017
truSculpt
K172004 · PBX
Cutera, Inc.
General & Plastic Surgery · 30d
Cleared Aug 01, 2017
AED Sinuscope
K170285 · EOB
National Advanced Endoscopy Devices,...
Ear, Nose, Throat · 183d
Cleared Aug 01, 2017
LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
K170565 · QYX
Lifewatch Services, Inc.
Cardiovascular · 155d
Cleared Aug 01, 2017
DD cubeX2 HS
K170885 · EIH
Dental Direkt GmbH
Dental · 127d
Cleared Aug 01, 2017
Zirconia Dental Ceramics
K170894 · EIH
Chengdu Besmile Biotechnology Co., Ltd.
Dental · 127d
Cleared Aug 01, 2017
BP5S Wireless Blood Pressure Monitor
K171062 · DXN
Andon Health Co, Ltd.
Cardiovascular · 113d
Cleared Aug 01, 2017
Calix-C Cervical Interbody Spacer
K171075 · ODP
X-Spine Systems, Inc.
Orthopedic · 112d
Cleared Aug 01, 2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
K171077 · HQD
Contamac, Ltd.
Ophthalmic · 112d
Cleared Aug 01, 2017
Q-Switched Nd:YAG Laser System
K171079 · GEX
Ids, Ltd.
General & Plastic Surgery · 112d
Cleared Aug 01, 2017
Advanced RBC Application
K171315 · JOY
CellaVision AB
Hematology · 89d
Cleared Aug 01, 2017
M.U.S.T. MINI Posterior Cervical Screws System
K171369 · NKG
Medacta International S.A.
Orthopedic · 83d
Cleared Aug 01, 2017
14Fr Colon Decompression Set, Macon Colon Decompression Set
K171619 · FEG
Cook Ireland, Ltd.
Gastroenterology & Urology · 60d
Cleared Aug 01, 2017
Trojan Supra Lubricated Polyurethane Male Condom
K171639 · MOL
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 60d
Cleared Aug 01, 2017
M.U.S.T. Combined Set Screws
K171758 · NKB
Medacta International S.A.
Orthopedic · 48d
Cleared Aug 01, 2017
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K171870 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Aug 01, 2017
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
K171906 · JWY
Liofilchem S. R. L.
Microbiology · 36d
Cleared Aug 01, 2017
HardyDisk AST Delafloxacin 5 µg (DLX5)
K171975 · JTN
Hardy Diagnostics
Microbiology · 32d
Cleared Jul 31, 2017
Electronic Blood Pressure Monitor
K161845 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 391d
Cleared Jul 31, 2017
bellavista 1000
K163127 · CBK
Imtmedical AG
Anesthesiology · 265d