Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
157657–157680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1983
CLOSTRIDIUM DIFFICLE MEDIA
K831279 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 14d
Cleared May 09, 1983
PRO-SCOPE
K822085 · FER
Exitec, Inc.
Gastroenterology & Urology · 300d
Cleared May 09, 1983
MEDIGROUP LS-110 LIGHT SOURCE
K823294 · HET
Medigroup
Obstetrics & Gynecology · 185d
Cleared May 09, 1983
SEPTOPACK
K830113 · EMA
North Pacific Dental, Inc.
Dental · 118d
Cleared May 09, 1983
CUSTOM IV SET
K830182 · FPA
Custom Medical, Inc.
General Hospital · 111d
Cleared May 09, 1983
PROTET SOAP & WASH MITT
K830259 · GED
Ritmed, Inc.
General & Plastic Surgery · 104d
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