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
40057–40080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2013
SOFIA(R) HCG FIA
K131166 · JHI
Quidel Corp.
Chemistry · 100d
Cleared Aug 02, 2013
BD FACS SAMPLE PREP ASSISTANT III
K131301 · PER
Becton, Dickinson & CO
Immunology · 87d
Cleared Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493 · DQY
C.R. Bard, Inc.
Cardiovascular · 71d
Cleared Aug 02, 2013
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
K131517 · FPK
Medrad, Inc. / Bayer Medical Care, Inc.
General Hospital · 66d
Cleared Aug 02, 2013
RESTORELLE M, RESTORELLE XL
K132061 · OTO
Coloplast Corp.
Obstetrics & Gynecology · 30d
Cleared Aug 01, 2013
MYOVISION 3.0 WIREFREE SYSTEM
K123399 · IKN
Precision Biometrics, Inc.
Neurology · 269d
Cleared Aug 01, 2013
CARDIO VISION MICS AORTIC CLAMPS
K123571 · DXC
Cardiomedical GmbH
Cardiovascular · 254d
Cleared Aug 01, 2013
TOGGLELOC XTENDER
K130033 · MBI
Biomet Manufacturing Corp
Orthopedic · 209d
Cleared Aug 01, 2013
ENDOGRAPH DC
K130109 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 197d
Cleared Aug 01, 2013
INTRA-LOCK OP DENTAL IMPLANT
K130140 · DZE
Intra-Lock International
Dental · 191d
Cleared Aug 01, 2013
AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
K130345 · NUC
Mayer Laboratories, Inc.
Obstetrics & Gynecology · 171d
Cleared Aug 01, 2013
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM,...
K130814 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 129d
Cleared Aug 01, 2013
PASSPORT ROBOTIC REDUCER CAP
K130826 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 128d
Cleared Aug 01, 2013
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
K131079 · DYB
Creganna Medical Devices
Cardiovascular · 106d
Cleared Aug 01, 2013
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
K131305 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 86d
Cleared Jul 31, 2013
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
K123908 · KKY
Matrix Surgical USA
General & Plastic Surgery · 224d
Cleared Jul 31, 2013
ABL90 FLEX
K130144 · CHL
Radiometer Medical Aps
Chemistry · 190d
Cleared Jul 31, 2013
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE...
K130181 · NBW
Infopia Co, Ltd.
Chemistry · 187d
Cleared Jul 31, 2013
5F DIGNITY CT TITANIUM PORT
K130923 · LJT
Medical Components, Inc.
General Hospital · 119d
Cleared Jul 31, 2013
JBAIDS PLAGUE DETECTION KIT
K131729 · OIH
Biofire Diagnostics, Inc.
Microbiology · 49d
Cleared Jul 31, 2013
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
K131754 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 47d
Cleared Jul 31, 2013
JBAIDS TULAREMIA DETECTION KIT
K131936 · OEH
Biofire Diagnostics, Inc.
Microbiology · 34d
Cleared Jul 31, 2013
NMI PICC III CATHETER, NMI HPICC III CATHETER
K131942 · LJS
Navilyst Medical, Inc.
General Hospital · 34d
Cleared Jul 31, 2013
VIAL CONNECTOR 13MM CLOSED COLLAR
K132040 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 29d