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
156817–156840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1983
TOILET SEAT RAISED
K830425 · ILS
Maddak, Inc.
Physical Medicine · 89d
Cleared May 09, 1983
DENTA A-33
K830439 · EGG
Denta, Inc.
Dental · 88d
Cleared May 09, 1983
WIDEX HEARING AID #G2H & G2T
K830465 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 83d
Cleared May 09, 1983
CARDIOMEMO III
K830477 · DXH
Instromedix, Inc.
Cardiovascular · 83d
Cleared May 09, 1983
SYSMEX CC-130
K830505 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 81d
Cleared May 09, 1983
SYSMEX CC-150
K830506 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 81d
Cleared May 09, 1983
SYSMEX CC-180
K830508 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 81d
Cleared May 09, 1983
FIRST TM
K830513 · EBF
Phasealloy
Dental · 81d
Cleared May 09, 1983
CYTOMEGELISA STAT
K830615 · LFZ
M.A. Bioproducts
Chemistry · 70d
Cleared May 09, 1983
TRACHEAL TUBE W/ILLUMINATING LOCATER
K830631 · BTR
Mallinckrodt Critical Care
Anesthesiology · 69d
Cleared May 09, 1983
HUMAN INTRACT PARATHYROID HORMONE BY
K830664 · CEW
Immuno Nuclear Corp.
Chemistry · 67d
Cleared May 09, 1983
POROUS TIP ENDOCARDIAL LEAD
K830743 · DTB
Daig Corp.
Cardiovascular · 62d
Cleared May 09, 1983
PRESSURE FUNCTION BLOCK FOR BLOOD PRESS
K830779 · DRT
Honeywell, Inc.
Cardiovascular · 59d
Cleared May 09, 1983
HARRIS A.R. C. ACETABULAR CUP
K830857 · JDI
Howmedica Corp.
Orthopedic · 53d
Cleared May 09, 1983
SURGITEKS PERCUTANEOUS ANTEGRADE ALL -
K830884 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 49d
Cleared May 09, 1983
DEXON 'S' POLYGLYCOLIC ACID MESH
K830889 · FTM
Davis & Geck, Inc.
General & Plastic Surgery · 49d
Cleared May 09, 1983
DENTAL CERAMIC FOR FABRICATION OF CROWN
K830955 · EIH
Dentsply Intl.
Dental · 45d
Cleared May 09, 1983
MASKS
K830982 · BSJ
Medovations, Inc.
Anesthesiology · 41d
Cleared May 09, 1983
AIRWAYS & NASOPHARYNGEAL TYPE
K830983 · BTQ
Medovations, Inc.
Anesthesiology · 41d
Cleared May 09, 1983
HEAD STRAP
K831008 · BTK
Medovations, Inc.
Anesthesiology · 40d
Cleared May 09, 1983
BUFFER PACK FOR ABL-1 & ABL-2
K831017 · CHL
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared May 09, 1983
FLUSH SOLUTION CONCENTRATE
K831020 · CHL
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared May 09, 1983
TI-1000 TRANSPORT INCUBATOR
K831028 · FPL
Narco Scientific
General Hospital · 40d
Cleared May 09, 1983
COBAS STANDARDS FOR GLUCOSE & BUN
K831030 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 40d