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
127633–127656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1990
HANDI PORCH ELEVATOR
K897019 · ING
The Cheney Co.
Physical Medicine · 24d
Cleared Jan 12, 1990
LINCOLN MILLS FOOT AND LEG HOLDER
K897028 · FWZ
Lincoln Mills, Inc.
General & Plastic Surgery · 24d
Cleared Jan 12, 1990
MODIFIED SPIROSCAN 1000
K897094 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 23d
Cleared Jan 12, 1990
FORTRESS 755FS PEDIATRIC WHEELCHAIR
K900037 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS 760FS POWER WHEELCHAIR
K900038 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS VICTORY POWER WHEELCHAIR
K900039 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS SPIRIT POWER WHEELCHAIR
K900040 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS LIBERATOR RWD SCOOTER
K900041 · INI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER
K900042 · INI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 11, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K891277 · LYY
Grace River Ent., Inc.
General Hospital · 302d
Cleared Jan 11, 1990
SENSI TOUCH PATIENT EXAM GLOVES (VINYL)
K892078 · LYZ
Taiwan Old Shop Corp.
General Hospital · 283d
Cleared Jan 11, 1990
PATIENT EXAMINATION GLOVES (VINYL)
K892180 · LYZ
Singfar Ent. Co. , Ltd.
General Hospital · 282d
Cleared Jan 11, 1990
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
K893991 · KPO
P & A Co.
Gastroenterology & Urology · 220d
Cleared Jan 11, 1990
TOTAL GALACTOSE
K894011 · KQP
Alpkem Corp.
Chemistry · 219d
Cleared Jan 11, 1990
PVC EXAMINATION GLOVES
K894752 · LYZ
Dan Dong Linsen Plastic Industrial...
General Hospital · 169d
Cleared Jan 11, 1990
ACE WIRE TENSION CLAMP
K894982 · JEC
Buckman Co., Inc.
Orthopedic · 156d
Cleared Jan 11, 1990
BATEMAN UPF II HIP PROSTHESIS SYSTEM
K895120 · KWY
3M Company
Orthopedic · 149d
Cleared Jan 11, 1990
AMICON MINIFILTER PLUS HEMOFILTER
K895405 · KDI
Amicon, Inc.
Gastroenterology & Urology · 126d
Cleared Jan 11, 1990
WELLCOLEX COLOUR SHIGELLA TEST ZC51
K895461 · GNB
Wellcome Diagnostics
Microbiology · 127d
Cleared Jan 11, 1990
MEDICOOL, CONTAINER FOR STORING INSULIN
K895674 · LDQ
Medicool, Inc.
General & Plastic Surgery · 113d
Cleared Jan 11, 1990
SODIUM AND POTASSIUM STANDARD
K895717 · JIX
Data Medical Associates, Inc.
Chemistry · 108d
Cleared Jan 11, 1990
BITOME(TM) BIPOLAR SPHINCTEROTOME
K895842 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 101d
Cleared Jan 11, 1990
WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
K895900 · FCK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Jan 11, 1990
TRIGLYCERIDES TEST KIT
K895952 · CDT
Elite Technology, Inc.
Chemistry · 92d