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
61609–61632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 2006
RESOLUTIONMD, VERSION 1.3
K062164 · LLZ
Calgary Scientific, Inc.
Radiology · 56d
Cleared Sep 22, 2006
ARCHITECT CORTISOL ASSAY
K062204 · JFT
Seradyn, Inc.
Chemistry · 52d
Cleared Sep 22, 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
K062334 · JIX
Dade Behring, Inc.
Chemistry · 43d
Cleared Sep 22, 2006
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE...
K062531 · NTE
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 24d
Cleared Sep 22, 2006
TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT
K062618 · IYE
Varian Medical Systems, Inc.
Radiology · 17d
Cleared Sep 22, 2006
MODIFICATION TO SYNGO INSPACE 4D
K062673 · JAK
Siemens AG Medical Solutions
Radiology · 14d
Cleared Sep 21, 2006
SURGI-WRAP MAST BIORESORBABLE SHEET
K061473 · FTL
Mast Biosurgery USA, Inc.
General & Plastic Surgery · 114d
Cleared Sep 21, 2006
DERMADAPT WOUND DRESSING
K061494 · KGN
Pegasus Biologics, Inc.
General & Plastic Surgery · 113d
Cleared Sep 21, 2006
SONICWELD RX ENDOBROW FIXATION
K061507 · JEY
KLS-Martin L.P.
Dental · 112d
Cleared Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Sep 21, 2006
SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
K061910 · HSB
Synthes (Usa)
Orthopedic · 77d
Cleared Sep 21, 2006
TYTAN BLOOD PRESSURE CUFF
K062238 · DXQ
Tytan Medical Corp.
Cardiovascular · 50d
Cleared Sep 21, 2006
EASYSTAND EVOLV
K062402 · INO
Invacare Corp.
Physical Medicine · 35d
Cleared Sep 21, 2006
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM
K062423 · GEX
Omniguide, Inc.
General & Plastic Surgery · 34d
Cleared Sep 21, 2006
KIT MENDEC SPINE AND DELIVERY SYSTEM
K062452 · NDN
Tecres S.P.A.
Orthopedic · 30d
Cleared Sep 21, 2006
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · MEB
Baxter Healthcare Corporation
General Hospital · 29d
Cleared Sep 21, 2006
MODIFICATION TO HEXAPOD RT COUCH TOP
K062639 · JAI
Medical Intelligence...
Radiology · 15d
Cleared Sep 21, 2006
EP NAVIGATOR SOFTWARE
K062650 · LLZ
Philips Medical Systems
Radiology · 14d
Cleared Sep 20, 2006
THERMOSUIT SYSTEM
K061023 · NZE
Life Recovery Systems Hd, LLC
Cardiovascular · 160d
Cleared Sep 20, 2006
LEICA MODEL FL800
K061871 · IZI
Leica Microsystems, Inc.
Radiology · 79d
Cleared Sep 20, 2006
NAVIVISION
K062086 · HAW
Brainlab AG
Neurology · 61d
Cleared Sep 20, 2006
AVEA VENTILATOR
K062093 · CBK
Viasys Respiratory Care, Inc.
Anesthesiology · 58d
Cleared Sep 20, 2006
FETCH ASPIRATION CATHETER
K062172 · QEZ
Possis Medical, Inc.
Cardiovascular · 51d
Cleared Sep 20, 2006
RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
K062275 · QEZ
Kerberos Proximal Solutions, Inc.
Cardiovascular · 44d