FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
125641–125664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1990
COMBINATION REAMER
K903248 · HTO
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
BLADE PLATE
K903250 · KTT
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
JEWETT HIP NAIL
K903251 · KTT
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
HANSEN-STREET TYPE INTRAMEDULLARY NAIL
K903256 · HSB
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
DRIVER/EXTRACTOR
K903257 · LXH
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
RUSH PIN
K903261 · JDW
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
K-WIRE
K903264 · HTY
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
STEINMAN PIN
K903265 · HTY
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
STEINMAN PIN, THREAD
K903266 · JDW
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
T-HANDLE HEX WRENCH
K903270 · LXH
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
ROUND STAPLE
K903271 · JDR
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
BARBED SQUARE STAPLE
K903273 · JDR
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 27, 1990
NEMECTRON MICROWAVE
K895000 · IOA
Nemectron Medical, Inc.
Physical Medicine · 353d
Cleared Jul 27, 1990
HOLLOW FIBER DIALYZER, BIO CARE PS 130
K900018 · KDI
National Medical Care, Medical...
Gastroenterology & Urology · 206d
Cleared Jul 27, 1990
WILSON-COOK BILIARY MOTILITY CATHETER
K900058 · FFX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 205d
Cleared Jul 27, 1990
MODEL #M8 ELECTRONIC STERILIZER
K900432 · FLE
Midmark Corp.
General Hospital · 178d
Cleared Jul 27, 1990
IMX CMV IGM ANTIBODY ASSAY
K900473 · LFZ
Abbott Laboratories
Microbiology · 176d
Cleared Jul 27, 1990
IMX CMV IGG ANTIBODY ASSAY
K900474 · LFZ
Abbott Laboratories
Microbiology · 176d
Cleared Jul 27, 1990
INTERPORE IMZ SINGLE TOOTH ATTACHMENT SYSTEM
K900793 · DZE
Interpore Intl.
Dental · 157d
Cleared Jul 27, 1990
OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION
K900877 · HQY
Sunglass Originals, Inc.
Ophthalmic · 151d
Cleared Jul 27, 1990
REXTON RX12 POWER PLUS W/DUAL RECEIVER
K901341 · ESD
Rexton, Inc.
Ear, Nose, Throat · 127d
Cleared Jul 27, 1990
TRANSDUCER PROTECTOR
K901409 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 123d
Cleared Jul 27, 1990
GC-1000 THROUGH GC-3005 ACID CONCENTRATE
K901471 · KPO
Granite Chemical Co., Inc.
Gastroenterology & Urology · 121d
Cleared Jul 27, 1990
GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS
K901472 · KPO
Granite Chemical Co., Inc.
Gastroenterology & Urology · 121d