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

Filters: Cleared only ×
176,076 results
65521–65544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2005
1,25-DIHYDROXY VITAMIN D EIA
K051110 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 65d
Cleared Jul 06, 2005
ELECSYS CA 19-9 CALCHECK
K051185 · JJY
Roche Diagnostics Corp.
Immunology · 58d
Cleared Jul 06, 2005
RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT
K051268 · GEX
Radiancy, Ltd.
General & Plastic Surgery · 51d
Cleared Jul 06, 2005
NORWOOD ABBEY CENTURION SES EPIKERATOME
K051486 · HNO
Norwood Abbey , Ltd.
Ophthalmic · 30d
Cleared Jul 06, 2005
DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR
K051498 · LYZ
Ever Global Enterprise Corporation
General Hospital · 29d
Cleared Jul 05, 2005
FRAXEL SR LASER SYSTEM
K050841 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 95d
Cleared Jul 05, 2005
DCL MICROALBUMIN ASSAY, MODEL 252-20
K051191 · DCF
Diagnostic Chemicals , Ltd.
Chemistry · 56d
Cleared Jul 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML
K051266 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
K051517 · JJY
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Jul 01, 2005
EYE-CEPT REWETTING DROPS
K041008 · LPN
Optics Laboratory, Inc.
Ophthalmic · 438d
Cleared Jul 01, 2005
COMPEL 1-PLY SURGICAL GOWNS
K041653 · FYA
Standard Textile Co., Inc.
General Hospital · 379d
Cleared Jul 01, 2005
INSTANT-X, MODELS 1713 & 128
K042791 · MQB
Ann Arbor Digital Devices
Radiology · 267d
Cleared Jul 01, 2005
NAVIGATOR
K042875 · IYE
Nomos Corp.
Radiology · 256d
Cleared Jul 01, 2005
OMEGA EXCEL/XP LASER SYSTEM
K043353 · NHN
Advanced Medical Technologies, Inc.
Physical Medicine · 207d
Cleared Jul 01, 2005
TESLAOXYSAT, MODEL EFOXYSATE
K050018 · DQA
Mammendorfer Institute For Physics &...
Anesthesiology · 178d
Cleared Jul 01, 2005
TRANSEAR BONE CONDUCTION HEARING AID
K050653 · LXB
United Hearing Systems, Inc.
Ear, Nose, Throat · 112d
Cleared Jul 01, 2005
PMP4 MEDICAL WEB CENTER
K050940 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 78d
Cleared Jul 01, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE...
K051106 · DXN
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 60d
Cleared Jul 01, 2005
SMITH & NEPHEW CDS SYSTEM
K051136 · JAA
Smith & Nephew, Inc.
Radiology · 58d
Cleared Jul 01, 2005
55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS...
K051184 · LPL
United Contact Lens, Inc.
Ophthalmic · 53d
Cleared Jul 01, 2005
LUMIPHASE-R
K051255 · GEX
Opusmed, Inc.
General & Plastic Surgery · 46d
Cleared Jul 01, 2005
DIRECT DIGITIZER REGIUS MODEL 370
K051418 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 30d
Cleared Jul 01, 2005
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
K051423 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 30d
Cleared Jul 01, 2005
SYMBIOS DISPOSABLE INFUSION PUMP KIT
K051474 · MEB
Symbios Medical Products, LLC
General Hospital · 28d