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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
45025–45048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2012
SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K111841 · FMF
Chengdu Xinjin Shifeng Med Appratus...
General Hospital · 246d
Cleared Mar 01, 2012
DUET MAGNA
K111947 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 237d
Cleared Mar 01, 2012
OASYS SURGICAL LIGHT CONTROLLER
K112133 · FTA
Oasys Healthcare
General & Plastic Surgery · 219d
Cleared Mar 01, 2012
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
K112507 · OLO
Mako Surgical Corporation
Orthopedic · 184d
Cleared Mar 01, 2012
AONGEN DENTAL COLLAGEN MATRIX
K112568 · OLR
Aeon Astron Europe B.V.
General & Plastic Surgery · 177d
Cleared Mar 01, 2012
CURAD COMPRESSION HOSIERY
K112769 · DWL
Medline Industries, Inc.
General Hospital · 160d
Cleared Mar 01, 2012
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS...
K113003 · NHA
Astra Tech, Inc.
Dental · 146d
Cleared Mar 01, 2012
PAIN-AID
K113037 · NUH
Pdi Works, LLC
Neurology · 141d
Cleared Mar 01, 2012
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K113188 · CAZ
PAJUNK GmbH Medizintechnologie
Anesthesiology · 122d
Cleared Mar 01, 2012
MAXMIXING BLOCK
K113232 · BZR
Maxtec, Inc.
Anesthesiology · 120d
Cleared Mar 01, 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
K113238 · DXN
Health & Life Co., Ltd.
Cardiovascular · 120d
Cleared Mar 01, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K113249 · JSM
Puritan Medical Products, LLC
Microbiology · 119d
Cleared Mar 01, 2012
APNEARX
K113569 · LRK
Apnea Science Corporation
Dental · 90d
Cleared Mar 01, 2012
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
K120304 · FOS
Footprint Medical, Inc.
General Hospital · 29d
Cleared Feb 29, 2012
CLEANE / CLEANE POP
K111341 · OZC
Medicon Co., Ltd.
General & Plastic Surgery · 293d
Cleared Feb 29, 2012
QUANTUM BARIATRIC 451
K112815 · ITI
Pride Mobility Product Corporration
Physical Medicine · 155d
Cleared Feb 29, 2012
APEX REVISION KNEE SYSTEMS
K112891 · JWH
Omni Life Science, Inc.
Orthopedic · 152d
Cleared Feb 29, 2012
SONO TAP, TUOHY SONO
K113207 · BSP
Pajunk GmbH
Anesthesiology · 121d
Cleared Feb 29, 2012
INOMAX DS(DELIVERY SYSTEMS
K113272 · MRN
Ino Therapeutics, LLC/Dba Ikaria
Anesthesiology · 117d
Cleared Feb 29, 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364 · HRS
Synthes USA Products, LLC
Orthopedic · 106d
Cleared Feb 29, 2012
VANGUARD COMPLETE KNEE SYSTEM
K113550 · JWH
Biomet Manufacturing Corp
Orthopedic · 90d
Cleared Feb 29, 2012
DYNANAIL ANKLE ARTHRODESIS NAIL
K113828 · HSB
MedShape, Inc.
Orthopedic · 64d
Cleared Feb 29, 2012
HEALIX ADVANCE BR ANCHOR
K120078 · MAI
Depuy Mitek Inc., Johnson and Johnson...
Orthopedic · 50d
Cleared Feb 29, 2012
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA...
K120258 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 33d