FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
134977–135000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1988
DENVER PLEURO-PERITONEAL SHUNT
K880570 · KPM
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 131d
Cleared Jun 20, 1988
BARD PCA II INFUSION PUMP
K880733 · FRN
C.R. Bard, Inc.
General Hospital · 117d
Cleared Jun 20, 1988
HEMO SUC NUMBER HS100-HS205
K881036 · GCY
Instrumental Medico Croquevielle S.A.
General & Plastic Surgery · 102d
Cleared Jun 20, 1988
EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641
K881116 · KLR
Diagnostic Systems
Toxicology · 97d
Cleared Jun 20, 1988
VASCULAR CLAMP
K881158 · DXC
T. Korossurgical Instruments Corp.
Cardiovascular · 94d
Cleared Jun 20, 1988
CAVITRON ELECTROSURGICAL MODULE (CEM) AND PAK
K881687 · GEI
Cavitron Surgical Systems
General & Plastic Surgery · 62d
Cleared Jun 20, 1988
COLORADO NEEDLE ELECTRODE
K881763 · JOS
Colorado Biomedical, Inc.
General & Plastic Surgery · 56d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K881990 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K881991 · DIF
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
EXTENDED LIFE INJECTION SITE
K882007 · FPA
Baxter Healthcare Corp
General Hospital · 38d
Cleared Jun 20, 1988
SHARPLAN MEDILAS 4060 N
K882037 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 35d
Cleared Jun 20, 1988
C-FLO SUCTION TUBE
K882121 · DXQ
Concept, Inc.
Cardiovascular · 32d
Cleared Jun 20, 1988
HELENA REP GEL PROCESSOR
K882163 · JJN
Helena Laboratories
Chemistry · 27d
Cleared Jun 20, 1988
LANDMARK(TM) VENOUS ACCESS DEVICE
K882242 · FOZ
Menlo Care, Inc.
General Hospital · 31d
Cleared Jun 20, 1988
RETROFIT BABY FACE SHIELD (RFS)
K882291 · LBI
Physician Engineered Products, Inc.
General Hospital · 19d
Cleared Jun 17, 1988
MODIFIED COPE SUTURE ANCHOR
K873606 · FGE
Cook, Inc.
Gastroenterology & Urology · 283d
Cleared Jun 17, 1988
PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE
K875212 · EHD
Kevex Corp.
Radiology · 182d
Cleared Jun 17, 1988
DUET (CONDOMS)
K880185 · HIS
American Laboratories, Inc.
Obstetrics & Gynecology · 154d
Cleared Jun 17, 1988
DUNFORD SURGEON'S STERILE GLOVES
K880480 · KGO
Phillippine Radiant C/O U.S. Polymer...
General Hospital · 134d
Cleared Jun 17, 1988
MDL-1 LASERTRIPTER
K880503 · FFK
Candela Laser Corp.
Gastroenterology & Urology · 130d
Cleared Jun 17, 1988
MCT MEDICAL BROWNE UROSCAN URODYNAMIC
K880504 · EXY
Mct Medical, Inc.
Gastroenterology & Urology · 133d
Cleared Jun 17, 1988
PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE
K881252 · GCX
Deknatel, Inc.
General Hospital · 86d
Cleared Jun 17, 1988
PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
K881378 · LXI
Pfizer, Inc.
Orthopedic · 77d