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
158329–158352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1982
LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM
K823122 · JSI
Granite Diagnostics, Inc.
Pathology · 42d
Cleared Dec 03, 1982
OCTAPETTES
K823137 · JTC
Corning Costar Corp.
Hematology · 39d
Cleared Dec 03, 1982
SMITH'S MEDIUM
K823139 · JSJ
Granite Diagnostics, Inc.
Microbiology · 39d
Cleared Dec 03, 1982
CALMSET 3 TM
K823146 · HCC
Thought Technology , Ltd.
Neurology · 39d
Cleared Dec 03, 1982
BIPOLAR COAGULATOR #9620/9621
K823184 · GEI
Concept, Inc.
General & Plastic Surgery · 38d
Cleared Dec 03, 1982
GASTRIC LAVAGE KIT
K823195 · KNT
Autovage
Gastroenterology & Urology · 38d
Cleared Dec 03, 1982
LIQUIZYME CALCIUM REAGENT SET
K823219 · CIC
American Research Products Co.
Chemistry · 36d
Cleared Dec 03, 1982
STERILE WATER SYSTEM
K823230 · EIA
Syntex Dental Products, Inc.
Dental · 35d
Cleared Dec 03, 1982
CAP-RIA 16
K823240 · JJJ
Capintec, Inc.
Chemistry · 32d
Cleared Dec 03, 1982
SCHAEDLER AGARS
K823248 · JSJ
Granite Diagnostics, Inc.
Microbiology · 32d
Cleared Dec 03, 1982
AUTOPAK FERRITIN TEST DELIVERY SYS
K823275 · DBF
Micromedic Systems
Chemistry · 30d
Cleared Dec 03, 1982
FLUSHING SOLUTION
K823283
Nobel Scientific Industries, Inc.
Hematology · 29d
Cleared Dec 03, 1982
MICROPAD
K823301 · IRT
Fia Man Co.
Physical Medicine · 28d
Cleared Dec 03, 1982
MYCAREL AGAR MYCOBROTIC AGAR
K823308 · JSJ
Troy Biologicals, Inc.
Microbiology · 28d
Cleared Dec 03, 1982
MARTIN & LEMIS AGAR W/VCAT INHIBITOR
K823309 · JTY
Troy Biologicals, Inc.
Microbiology · 28d
Cleared Dec 03, 1982
ELASTIC COMPRESSION ANKLET
K823350 · FQL
Podiatry Products Corp.
General Hospital · 24d
Cleared Dec 03, 1982
READY-BOX BODY-TEMP MEDIA WARMER MALLIN-
K823356 · DXT
Forma Scientific, Inc.
Cardiovascular · 24d
Cleared Dec 03, 1982
SURGICAL LIGHT
K823360 · FTD
Amsco Co.
General & Plastic Surgery · 28d
Cleared Dec 03, 1982
ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY
K823370 · KJI
Syva Co.
Toxicology · 23d
Cleared Dec 03, 1982
OCTAGONAL ALUMINUM FRAMING SYSTEM
K823372 · HST
Orthopedic Systems, Inc.
Neurology · 21d
Cleared Dec 03, 1982
CERA 8
K823377 · EIH
Cer-Met, Inc.
Dental · 21d
Cleared Dec 03, 1982
CERA COLOR
K823378 · EIH
Cer-Met, Inc.
Dental · 21d
Cleared Dec 03, 1982
STAX FINGER SPLINTS
K823393 · ILH
Orthopedic Systems, Inc.
Physical Medicine · 21d
Cleared Dec 03, 1982
WALKING HEEL
K823394 · LGF
Orthopedic Systems, Inc.
Orthopedic · 21d