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
55201–55224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2008
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
K082667 · EOB
Visionsense, Ltd.
Ear, Nose, Throat · 48d
Cleared Oct 30, 2008
AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
K082717 · JJY
Aalto Scientific, Ltd.
Immunology · 43d
Cleared Oct 30, 2008
UNITY BETA ANCHOR SYSTEM
K082906 · HWC
Bonutti Research, Inc.
Orthopedic · 30d
Cleared Oct 30, 2008
CHROMOPHARE E 778 AND E 558
K083066 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 15d
Cleared Oct 29, 2008
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
K073307 · JEY
Bio-Technology USA, Inc.
Dental · 341d
Cleared Oct 29, 2008
FLOWMEDICA BENEPHIT INFUSION SYSTEMS
K082163 · KRA
Flowmedica, Inc.
Cardiovascular · 90d
Cleared Oct 29, 2008
DURASHIELD PLUS
K082198 · LBH
Dentsply Intl., Inc.
Dental · 86d
Cleared Oct 29, 2008
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · HAW
Smith & Nephew, Inc.
Neurology · 79d
Cleared Oct 29, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP...
K082357 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 72d
Cleared Oct 29, 2008
PINNACLE ROII INTRODUCER SHEATH
K082847 · DYB
Terumo Medical Corp.
Cardiovascular · 30d
Cleared Oct 29, 2008
APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K083021 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 20d
Cleared Oct 28, 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
K082183 · CAZ
PAJUNK GmbH Medizintechnologie
Anesthesiology · 88d
Cleared Oct 28, 2008
DEVILBISS DV5M SMARTLINK SYSTEM
K082209 · BZD
Sunrise Medical
Anesthesiology · 84d
Cleared Oct 28, 2008
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
K082314 · IOR
Otto Bock Healthcare LP
Physical Medicine · 76d
Cleared Oct 28, 2008
OPTIFLUX F250NR, MODEL 0500325E
K082414 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 68d
Cleared Oct 28, 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · LZG
Roche Diagnostics
General Hospital · 50d
Cleared Oct 28, 2008
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
K082721 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 41d
Cleared Oct 28, 2008
P & F POWER WHEELCHAIR, MODEL HC-500SB
K082722 · ITI
P & F Brother Ind., Corp.
Physical Medicine · 41d
Cleared Oct 28, 2008
DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000
K082798 · KPR
Medicatech USA
Radiology · 35d
Cleared Oct 28, 2008
VTI INTRAOPERATIVE DOPPLER SYSTEMS
K082870 · DPW
Vascular Technology Incorporated
Cardiovascular · 29d
Cleared Oct 28, 2008
KYMCO FORU, MODEL EQ10
K082900 · INI
Kwang Yang Motor Co., Ltd.
Physical Medicine · 28d
Cleared Oct 28, 2008
KYMCO FORU, MODEL EQ20
K082901 · INI
Kwang Yang Motor Co., Ltd.
Physical Medicine · 28d
Cleared Oct 27, 2008
PRECISION OXYGEN CONCENTRATOR
K072348 · CAW
Precision Medical, Inc.
Anesthesiology · 433d
Cleared Oct 27, 2008
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
K080339 · BTR
Medsource International, LLC
Anesthesiology · 262d