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
74521–74544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2002
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
K023511 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Nov 05, 2002
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K023586 · MQB
Canon USA, Inc.
Radiology · 11d
Cleared Nov 04, 2002
AUTOCON II 400 ELECTROSURGICAL GENERATOR
K021467 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 181d
Cleared Nov 04, 2002
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
K021576 · CCK
Mercury Medical
Anesthesiology · 174d
Cleared Nov 04, 2002
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION
K021732 · KDI
Dideco S.P.A.
Gastroenterology & Urology · 164d
Cleared Nov 04, 2002
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K022007 · MOS
Usa Instruments, Inc.
Radiology · 138d
Cleared Nov 04, 2002
PHLEBOTEST 2000
K022047 · JOM
Osborn Medical Corp.
Cardiovascular · 133d
Cleared Nov 04, 2002
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
K022751 · KGE
Medical Device Services
Gastroenterology & Urology · 77d
Cleared Nov 04, 2002
HYALURONIDASE SOLUTION
K022931 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 61d
Cleared Nov 04, 2002
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
K022948 · HIB
Medical Action Industries, Inc.
Obstetrics & Gynecology · 60d
Cleared Nov 04, 2002
CERANUM 50
K023199 · EJT
Sb Lucius, Inc.
Dental · 40d
Cleared Nov 04, 2002
CERANUM 76
K023200 · EJT
Sb Lucius, Inc.
Dental · 40d
Cleared Nov 04, 2002
HEMCON BANDAGE
K023298 · QSY
Hemcon, Inc.
General & Plastic Surgery · 32d
Cleared Nov 04, 2002
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · KKX
Medline Industries, Inc.
General Hospital · 20d
Cleared Nov 04, 2002
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497 · MSX
Datex-Ohmeda
Cardiovascular · 17d
Cleared Nov 04, 2002
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
K023569 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 11d
Cleared Nov 04, 2002
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 6d
Cleared Nov 01, 2002
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
K011005 · FIP
Pure Water Solutions, Inc.
Gastroenterology & Urology · 576d
Cleared Nov 01, 2002
REGENECARE WOUND GEL
K020540 · SEJ
Mpm Medical., Inc.
General & Plastic Surgery · 255d
Cleared Nov 01, 2002
PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US
K020886 · BZD
Tyco Healthcare Nancy
Anesthesiology · 228d
Cleared Nov 01, 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · MQV
Biocomposites, Ltd.
Orthopedic · 172d
Cleared Nov 01, 2002
SYNTHES LOW PROFILE NEURO SYSTEM
K022012 · JEY
Synthes (Usa)
Dental · 134d
Cleared Nov 01, 2002
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
K022021 · GFO
Vital Scientific N.V.
Hematology · 134d
Cleared Nov 01, 2002
THOMAS MEDICAL ELECTRODES
K022593 · HGI
Thomas Medical, Inc.
Obstetrics & Gynecology · 88d