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
38209–38232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2014
N-FORCE FIXATION SYSTEM
K132244 · HWC
Innovision, Inc.
Orthopedic · 231d
Cleared Mar 06, 2014
MICROTABLE SYSTEM
K132611 · HAW
Fred Haer Company, Inc.
Neurology · 198d
Cleared Mar 06, 2014
UCP MULTI-DRUG TEST KEY CUPS
K132812 · DKZ
Ucp Biosciences, Inc.
Toxicology · 178d
Cleared Mar 06, 2014
ZEDVIEW
K133022 · LLZ
Lexi Co., Ltd.
Radiology · 161d
Cleared Mar 06, 2014
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
K133036 · MBI
Amendia, Inc.
Orthopedic · 161d
Cleared Mar 06, 2014
FLASH BITE
K133400 · ELW
3M Espe AG
Dental · 120d
Cleared Mar 06, 2014
ELITE IBF
K133459 · MAX
Innova Spinal Technologies, LLC
Orthopedic · 114d
Cleared Mar 06, 2014
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH...
K133754 · GWM
Integra LifeSciences Corporation
Neurology · 87d
Cleared Mar 06, 2014
OPTIGLAZE COLOR
K133836 · EBD
GC America, Inc.
Dental · 78d
Cleared Mar 06, 2014
MODEL-BASED RSA SOFTWARE
K133966 · LLZ
Halifax Biomedical, Inc.
Radiology · 72d
Cleared Mar 06, 2014
O2 NASAL CANNULA WITH CO2 MONITORING
K140113 · CCK
Flexicare Medical, Ltd.
Anesthesiology · 50d
Cleared Mar 06, 2014
VENTRIPOINT MEDICAL SYSTEM
K140153 · IYN
Ventripoint, Inc.
Radiology · 43d
Cleared Mar 05, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130751 · LYZ
Cabin Plastic Co., Ltd.
General Hospital · 351d
Cleared Mar 05, 2014
CONTEC ELECTROCARDIOGRAPH
K131900 · DPS
Contec Medical System Co., Ltd.
Cardiovascular · 253d
Cleared Mar 05, 2014
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR,...
K132714 · LPL
Vision Science Co., Ltd.
Ophthalmic · 187d
Cleared Mar 05, 2014
VELOFIXTM INTERBODY FUSION SYSTEM
K132926 · ODP
U&I Corp.
Orthopedic · 168d
Cleared Mar 05, 2014
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
K133254 · GEX
Cynosure, Inc.
General & Plastic Surgery · 134d
Cleared Mar 05, 2014
ALLURA XPER FD
K133292 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 131d
Cleared Mar 05, 2014
ANGIOVAC CANNULA
K133445 · DWF
Vortex Medical, Inc.
Cardiovascular · 113d
Cleared Mar 05, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
K133618 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 100d
Cleared Mar 05, 2014
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
K133619 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 100d
Cleared Mar 05, 2014
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI...
K133740 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 86d
Cleared Mar 05, 2014
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM,...
K140208 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 36d
Cleared Mar 05, 2014
IMMULITE 2000 DHEA-SO4
K140258 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d