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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
69385–69408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2003
BAY AREA HYPERSCIENCES
K030713 · CBF
Bay Area Hypersciences, LLC
Anesthesiology · 288d
Cleared Dec 19, 2003
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES...
K031260 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 242d
Cleared Dec 19, 2003
IXL DIABETES MANAGEMENT SYSTEM
K031373 · LZG
Insulet Corp.
General Hospital · 233d
Cleared Dec 19, 2003
MEDISCOPE
K031436 · HEX
Sometech Corporation
Obstetrics & Gynecology · 227d
Cleared Dec 19, 2003
INSTAREAD LITHIUM SYSTEM
K031579 · JIH
Akers Laboratories, Inc.
Toxicology · 213d
Cleared Dec 19, 2003
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
K031831 · HKO
Topcon Medical Systems, Inc.
Ophthalmic · 189d
Cleared Dec 19, 2003
BAYER CLINITEK STATUS ANALYZER
K031947 · KQO
Bayer Healthcare, LLC
Chemistry · 178d
Cleared Dec 19, 2003
REVOLUTION SPINAL FIXATION SYSTEM
K032219 · MNI
Spinal Innovations, Inc.
Orthopedic · 151d
Cleared Dec 19, 2003
IMMUNETECH TOTAL IGE SYSTEM
K032251 · DGC
Immunetech Corporation
Immunology · 150d
Cleared Dec 19, 2003
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288 · MQV
Orthovita, Inc.
Orthopedic · 148d
Cleared Dec 19, 2003
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH...
K032663 · DCK
Instrumentation Laboratory CO
Chemistry · 113d
Cleared Dec 19, 2003
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K032763 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 105d
Cleared Dec 19, 2003
PHENOL RED STOCK SOLUTION
K032887 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 94d
Cleared Dec 19, 2003
SHELHIGH NO-REACT BIOCUFF
K032893 · FTL
Shelhigh, Inc.
General & Plastic Surgery · 93d
Cleared Dec 19, 2003
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
K032928 · GZJ
Mediphysics Pain Centers of America
Neurology · 88d
Cleared Dec 19, 2003
YA-MAN LASER 21
K032944 · GEX
Ya-Man, Ltd.
General & Plastic Surgery · 88d
Cleared Dec 19, 2003
GEM INSET PATELLAR COMPONENT
K032950 · JWH
Kinamed, Inc.
Orthopedic · 88d
Cleared Dec 19, 2003
IMPAK ACRYLIC REPAIR RESIN LIQUID
K033020 · EBI
Cmp Industries, LLC
Dental · 84d
Cleared Dec 19, 2003
LIFESTYLES LIQUID PERSONAL LUBRICANT
K033076 · HIS
Ansell Healthcare, Inc.
Obstetrics & Gynecology · 81d
Cleared Dec 19, 2003
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
K033084 · MQF
Portex , Ltd.
Obstetrics & Gynecology · 81d
Cleared Dec 19, 2003
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161...
K033094 · DKZ
Lin-Zhi International, Inc.
Toxicology · 81d
Cleared Dec 19, 2003
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01,...
K033159 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 80d
Cleared Dec 19, 2003
WILSON-COOK TRI-TOME SELECT PLUS
K033203 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Dec 19, 2003
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280 · JDC
Biomet, Inc.
Orthopedic · 70d