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
153265–153288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1984
SWISS OPTICAL PRODUCTS-CONTACT CASE
K840115 · HQD
Moonbeam International, Inc.
Ophthalmic · 142d
Cleared Jun 01, 1984
SERVOMED DIGITAL DISPLAY MODULE
K840521 · DRT
Litton Medical Electronics
Cardiovascular · 115d
Cleared Jun 01, 1984
SERVOMED COMPACT MONITOR SMK 155-1/101
K840525 · DRT
Litton Medical Electronics
Cardiovascular · 115d
Cleared Jun 01, 1984
GORE-TEX CATHETER
K840864 · KNT
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 95d
Cleared Jun 01, 1984
CONTACT LENS INSERTER/REMOVER
K841163 · HQD
Optimum Manufacturers, Inc.
Ophthalmic · 74d
Cleared Jun 01, 1984
DIA REPTIN
K841365 · GIR
Diatech, Inc.
Hematology · 60d
Cleared Jun 01, 1984
DIA FIBRIN
K841366 · KQJ
Diatech, Inc.
Hematology · 60d
Cleared Jun 01, 1984
HEPARIN COAGULATION CONTROL PLASMA 1-
K841462 · JPA
Diatech, Inc.
Hematology · 53d
Cleared Jun 01, 1984
OWREN'S VERONAL BUFFERR
K841523 · JPA
Diatech, Inc.
Hematology · 50d
Cleared Jun 01, 1984
SERUM COMPLEMENT ACTIVITY TEST-SCAT
K841541 · DAK
Collaborative Research, Inc.
Immunology · 46d
Cleared Jun 01, 1984
VAST VENTREX RAST ALL
K841651 · DGC
Ventrex Laboratories, Inc.
Immunology · 42d
Cleared Jun 01, 1984
OCULAR PRESSURE APPLICATOR
K841652
The Lebanon Corp.
Ophthalmic · 42d
Cleared Jun 01, 1984
ACCUPRO ENTERAL FEEDING PUMP
K841729 · FRN
American Mcgaw
General Hospital · 37d
Cleared Jun 01, 1984
TAGO FIFFU-GEN, OROSOMUCOID
K841734 · LKL
Tago, Inc.
Immunology · 36d
Cleared Jun 01, 1984
OPHTHALMIC TABLE
K841759 · HMG
Woodlyn, Inc.
Ophthalmic · 35d
Cleared Jun 01, 1984
WOODLYN CLASSIC TRIAL LENS SET
K841766 · HPC
Woodlyn, Inc.
Ophthalmic · 35d
Cleared Jun 01, 1984
WOODLYN LIGHTWEIGHT TRIAL FRAME
K841768 · HPA
Woodlyn, Inc.
Ophthalmic · 35d
Cleared Jun 01, 1984
OPTIMATE IGA TEST
K841815 · CZN
Miles Laboratories, Inc.
Immunology · 31d
Cleared Jun 01, 1984
MICROSURGICAL KNIFE
K841951 · HNN
Ethicon, Inc.
Ophthalmic · 18d
Cleared Jun 01, 1984
BIPHASIC BLOOD CULTURE BOTTLE
K842036 · JSG
Gibco Laboratories Life Technologies,...
Microbiology · 11d
Cleared Jun 01, 1984
TITERTEK-ENTEROBAC RAPID AUTOMATED
K842182
Flow Laboratories, Inc.
Microbiology
Cleared May 31, 1984
SUTURE REMOVAL KITS STERILE
K833688 · KGX
Carwild Corp.
General & Plastic Surgery · 213d
Cleared May 31, 1984
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
K840976 · FSM
Carapace, Inc.
General & Plastic Surgery · 86d
Cleared May 31, 1984
MORWEL ASPIRATOR
K841160 · JCX
Morwel Corp.
General & Plastic Surgery · 73d