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
155953–155976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IGA A CHAIN
K832263 · CZP
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IGM H CHAIN
K832265 · DFT
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN KAPPA AFFINITY
K832266 · DFH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN LAMBA
K832267 · DES
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN LAMBA
K832270 · DEH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
ISOLATION BAG 3M
K832318 · KGY
3M Company
General & Plastic Surgery · 108d
Cleared Oct 31, 1983
CHANGING METHOD OF STERILITY RELEASE
K832368 · EMF
Devon Industries, Inc.
General & Plastic Surgery · 105d
Cleared Oct 31, 1983
AXIOM HYDROMER WOUND DRAINS
K832416 · GBS
Axiom Medical, Inc.
General & Plastic Surgery · 102d
Cleared Oct 31, 1983
ELECTRO-ACUSCOPE
K832442 · GZJ
Kenneth J. Purcell
Neurology · 98d
Cleared Oct 31, 1983
I.V. ADMINISTRATION SET
K832542 · FPA
Research Industries Corp.
General Hospital · 94d
Cleared Oct 31, 1983
TANDEM-E THYROID STIMULATING HORMONE KIT
K832813 · JLW
Hybritech, Inc.
Chemistry · 73d
Cleared Oct 31, 1983
MOTILITY MEASUREMENT SYS MMS-100
K832869 · FFX
Narco Bio-Systems
Gastroenterology & Urology · 68d
Cleared Oct 31, 1983
TRACHEOSTOMY CARE TRAYS
K832880 · JOL
Packaging Technologies, Inc.
General Hospital · 66d
Cleared Oct 31, 1983
VENOUS RESERVOIR
K832924 · DTN
Shiley, Inc.
Cardiovascular · 63d
Cleared Oct 31, 1983
FLEXIFLO ENTERAL FEEDING TUBE
K832966 · KNT
Abbott Laboratories
Gastroenterology & Urology · 60d
Cleared Oct 31, 1983
HOBBS MEDICAL GRASPING FORCEPS
K833125 · OCZ
Hobbs Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Oct 31, 1983
ONE TIME ACETONE/ALCOHOL
K833141 · LKB
Acme United Corp.
General Hospital · 47d
Cleared Oct 31, 1983
TRICHROME STAIN LG SOLUTION
K833167 · LED
Sigma Chemical Co.
Hematology · 45d
Cleared Oct 31, 1983
GLOSSECTOMY FEEDING SPOONS
K833177 · ILC
Maddak, Inc.
Physical Medicine · 42d
Cleared Oct 31, 1983
APLICARE ONE ACETONE ALCOHOL SWABSTICK
K833183 · LKB
Aplicare, Inc.
General Hospital · 42d
Cleared Oct 31, 1983
ACETONE ALCOHOL PREP PAD
K833185 · LKB
Aplicare, Inc.
General Hospital · 42d
Cleared Oct 31, 1983
HALL OSTEON
K833187 · GET
Amsco Co.
General & Plastic Surgery · 42d
Cleared Oct 31, 1983
SECURITY STRETCH BRIEF-MEDICAL
K833245 · KNX
Mb Products, Ltd.
Gastroenterology & Urology · 48d
Cleared Oct 31, 1983
ENDOSCOPIC OVERTUBE
K833268 · FED
Mill-Rose Laboratory
Gastroenterology & Urology · 40d