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
119593–119616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1991
AMISH COUNTRY SPA
K911758 · ILJ
Fox Pool Corp.
Physical Medicine · 167d
Cleared Oct 02, 1991
EYE BUBBLE
K912367 · HOY
Aaron Medical Industries
Ophthalmic · 126d
Cleared Oct 02, 1991
N80-838 SUPRAMID EXTRA SUTURE
K912429 · GAR
S. Jackson, Inc.
General & Plastic Surgery · 124d
Cleared Oct 02, 1991
LIATEST PROTEIN S KIT
K912468 · GGP
American Bioproducts Co.
Hematology · 120d
Cleared Oct 02, 1991
DEROYAL WOUND DRESSING
K912472 · MGO
Deroyal Industries, Inc.
General & Plastic Surgery · 120d
Cleared Oct 02, 1991
ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE
K912563 · FOZ
Mbo Laboratories, Inc.
General Hospital · 113d
Cleared Oct 02, 1991
MODULAR HIP SYSTEM
K912593 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 114d
Cleared Oct 02, 1991
INSTANT WARM GEL PACK
K912715 · IMD
Prism Technologies, Inc.
Physical Medicine · 106d
Cleared Oct 02, 1991
STERI-SWAB
K912731 · LKB
Westlock Investments (Usa), Inc.
General Hospital · 104d
Cleared Oct 02, 1991
PATIENT LIFT AND TRANSPORT
K912769 · FNG
Century Manufacturing Co.
General Hospital · 100d
Cleared Oct 02, 1991
PDI PARALLEL SIDED POST KIT
K913019 · ELR
Precident Corp.
Dental · 85d
Cleared Oct 02, 1991
SKINTEMP
K913023 · KGN
Biocore
General & Plastic Surgery · 85d
Cleared Oct 02, 1991
STERILESERT(TM) CABLE AND POLE DRAPE
K913047 · KKX
Arch Development Group
General Hospital · 85d
Cleared Oct 02, 1991
DW238 #228-34A
K913068 · EJS
Ivoclar North America, Inc.
Dental · 83d
Cleared Oct 02, 1991
DW238 #228-04B
K913069 · EJS
Ivoclar North America, Inc.
Dental · 83d
Cleared Oct 02, 1991
PALFIQUE LITEPOSTERIOR
K913099 · EBF
Tokuyama America, Inc.
Dental · 82d
Cleared Oct 02, 1991
PALFIQUE INLAY
K913100 · EBF
Tokuyama America, Inc.
Dental · 82d
Cleared Oct 02, 1991
UNIDIRECTIONAL OCCLUDER
K913230 · HOY
Welch Allyn, Inc.
Ophthalmic · 72d
Cleared Oct 02, 1991
THE PAN.OPTX SPORTGLASS
K913388 · HQY
Panoptx, Inc.
Ophthalmic · 65d
Cleared Oct 02, 1991
PERRY(R) DERMAGUARD(R) PLUS GLOVES
K913402 · KGO
Smith & Nephew Perry
General Hospital · 64d
Cleared Oct 02, 1991
OXYGEN MASKS 82400 & 82405
K913455 · BYG
Specialty Packaging Producs, Inc.
Anesthesiology · 61d
Cleared Oct 02, 1991
YSI MODEL 2300 STAT PLUS
K913806 · CGA
Ysis, Inc.
Chemistry · 37d
Cleared Oct 02, 1991
FASTTECH SYSTEM II
K913892 · DHB
3M Diagnostic Systems, Inc.
Immunology · 33d
Cleared Oct 02, 1991
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
K914068 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 21d