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
60193–60216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2007
CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION...
K063563 · LIT
Cordis Europa, N.V.
Cardiovascular · 99d
Cleared Mar 07, 2007
OPTI
K063646 · EIA
Camsight Co., Inc.
Dental · 90d
Cleared Mar 07, 2007
SURGI-WRAP MAST TENDON SHEET
K063648 · FTL
Mast Biosurgery USA, Inc.
General & Plastic Surgery · 90d
Cleared Mar 07, 2007
BD DIRECTIGEN EZ FLU A+B TEST
K063689 · PSZ
Becton, Dickinson & CO
Microbiology · 85d
Cleared Mar 07, 2007
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
K063694 · KYB
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Mar 07, 2007
BP-200 PLUS
K063814 · DXN
Schiller AG
Cardiovascular · 75d
Cleared Mar 07, 2007
SYNTHES (USA) ELBOW HINGE FIXATOR
K063832 · LXT
Synthes (Usa)
Orthopedic · 71d
Cleared Mar 07, 2007
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K070026 · LYZ
Shijiazhuang Lianhe Shunda Plastic...
General Hospital · 63d
Cleared Mar 07, 2007
OTOGRAM, CA3350
K070118 · EWO
Tympany, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 07, 2007
TROKABONE, TROKABONE STERNAL
K070179 · FCG
PAJUNK GmbH Medizintechnologie
Gastroenterology & Urology · 47d
Cleared Mar 07, 2007
ALPHA-CORE DC
K070191 · EBF
Dental Technologies, Inc.
Dental · 44d
Cleared Mar 07, 2007
PRE-LOADED VISICOIL
K070305 · IYE
Radiomed Corporation
Radiology · 34d
Cleared Mar 06, 2007
ZIRCONIA IMPLANT
K061971 · DZE
Nobel Biocare AB
Dental · 237d
Cleared Mar 06, 2007
VAP-NT CHOLESTEROL TEST
K062026 · CHH
Atherotech, Inc.
Chemistry · 231d
Cleared Mar 06, 2007
SAF-T-SYRINGE- 0.5 AND 1ML/CC
K063340 · MEG
Safety Medical International,...
General Hospital · 120d
Cleared Mar 06, 2007
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · HTY
Arthrex, Inc.
Orthopedic · 81d
Cleared Mar 06, 2007
PLC SUTURE ANCHOR
K063726 · HRS
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 81d
Cleared Mar 06, 2007
FORCETRIAD ELECTROSURGICAL GENERATOR
K070162 · GEI
Valleylab,A Division of Tyco...
General & Plastic Surgery · 48d
Cleared Mar 06, 2007
DEPUY ASR TAPER SLEEVE ADAPTER
K070359 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Mar 05, 2007
PS SERIES
K061622 · FFS
Photonic Optische Gerate Gesmbh & Cokg
Gastroenterology & Urology · 266d
Cleared Mar 05, 2007
CADWELL EASYNET OXIMETER MODULE
K061706 · DQA
Cadwell Laboratories, Inc.
Anesthesiology · 262d
Cleared Mar 05, 2007
JOYKEY SURGICAL DRAPES (STERILE)
K062480 · KKX
Joykey Industryial , Ltd.
General Hospital · 193d
Cleared Mar 05, 2007
T2 SCEPTOR SPINAL SYSTEM
K063491 · MQP
Medtronic Sofamor Danek
Orthopedic · 108d
Cleared Mar 05, 2007
LEKSELL GAMMA KNIFE PERFEXION
K063512 · IWB
Elekta Instrument AB
Radiology · 105d