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
130513–130536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1989
SARNS MEDICAL CART
K892052 · LDQ
3M Company
General & Plastic Surgery · 78d
Cleared Jun 15, 1989
ISL QC 2000
K892058 · LXS
Intelligent Surgical Lasers, Inc.
Ophthalmic · 78d
Cleared Jun 15, 1989
CANDELA PLDL-1 PULSED DYE LASER
K892516 · GEX
Candela Laser Corp.
General & Plastic Surgery · 65d
Cleared Jun 15, 1989
KINETIC MODEL 700
K892808 · FSY
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 59d
Cleared Jun 15, 1989
HARVESTING TUBE
K892857 · CAC
Conmedcorp
Anesthesiology · 58d
Cleared Jun 15, 1989
AUTOMATIC CRANIAL DRILL (PERFORATOR)
K892866 · HBF
Acra Cut, Inc.
Neurology · 57d
Cleared Jun 15, 1989
CRADLE, HOSPITAL BED CLOTHING
K892877 · FNJ
Warsaw Orthopedic, Inc.
General Hospital · 57d
Cleared Jun 15, 1989
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
K893707 · DRC
United States Surgical, A Division of...
Cardiovascular · 28d
Cleared Jun 15, 1989
COHERENT MARIE ARGON PHOTOCOAGULATOR
K893709 · HQF
Coherent Medical Group
Ophthalmic · 28d
Cleared Jun 14, 1989
ENTERAL FEEDING CONTAINER
K890424 · KNT
Multi-Med, Inc.
Gastroenterology & Urology · 139d
Cleared Jun 14, 1989
ARGEDENT 88, DENTAL ALLOY FOR PORCELAIN)
K891600 · EJT
Argen Precious Metals, Inc.
Dental · 86d
Cleared Jun 14, 1989
LAMINARIA TENT
K892220 · HDY
Berkeley Medevices
Obstetrics & Gynecology · 72d
Cleared Jun 14, 1989
ORALCHEK SUPER-SOFT BRUSH
K892264 · EFW
Pfizer, Inc.
Dental · 70d
Cleared Jun 14, 1989
KULZER TRANSLUX EC
K892456 · EBZ
Kulzer, Inc.
Dental · 65d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892624 · LYY
Sanital Co., Ltd.
General Hospital · 65d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892625 · LYY
Hand Care, Inc., Ltd.
General Hospital · 65d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES (POLY)
K892768 · LZA
Promedica Products, Inc.
General Hospital · 64d
Cleared Jun 14, 1989
ARGELITE 76SF+ DENTAL ALLOY
K892910 · EJT
Argen Precious Metals, Inc.
Dental · 55d
Cleared Jun 14, 1989
LATEX PATIENT EXAMINATION GLOVES
K892923 · LYY
Gigantic International Corp.
General Hospital · 62d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES
K892945 · LYY
R.J.M. Precaution Products, Inc.
General Hospital · 63d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES
K892961 · LYY
Viratect, Inc.
General Hospital · 63d
Cleared Jun 14, 1989
LATEX EXAM GLOVES (MFG. BROADLAND RUBBER INDUST.)
K892965 · LYY
Dmp, Inc.
General Hospital · 63d
Cleared Jun 14, 1989
JASONTEX LATEX EXAMINATION GLOVES
K893047 · LYY
Jasontex Co., Ltd.
General Hospital · 62d
Cleared Jun 14, 1989
VINYL EXAM GLOVES (MFG. TOPLAS INDUSTRIAL CO.)
K893098 · LYZ
Jason Co.
General Hospital · 61d