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
62809–62832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2006
SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM
K061213 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared May 16, 2006
OPTYSE OPHTHALMOSCOPE
K061278 · HLJ
Ophthalmos , Ltd.
Ophthalmic · 8d
Cleared May 15, 2006
AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS
K052290 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 265d
Cleared May 15, 2006
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT...
K052832 · MVN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 221d
Cleared May 15, 2006
MORTARA SURVEYOR TELEMETRY CENTRAL STATION
K060135 · MHX
Mortara Instrument, Inc.
Cardiovascular · 116d
Cleared May 15, 2006
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · DQD
American Diagnostic Corp.
Chemistry · 95d
Cleared May 15, 2006
PYRENEES CERVICAL PLATE SYSTEM
K060442 · KWQ
K2m, LLC
Orthopedic · 83d
Cleared May 15, 2006
ELLIPSE 12PL, MODEL 9ESL7228
K060516 · GEX
Danish Dermatologic Development A/S
General & Plastic Surgery · 77d
Cleared May 15, 2006
BISCEM TRANSLUCENT, BISCEM OPAQUE
K060701 · EMA
Bisco, Inc.
Dental · 60d
Cleared May 15, 2006
MODIFICATION TO: CARDIMA ABLATION SYSTEM
K060715 · OCL
Cardima, Inc.
Cardiovascular · 59d
Cleared May 15, 2006
AVANZA
K060870 · JAI
Mds Nordion
Radiology · 46d
Cleared May 15, 2006
MODIFICATION TO POWERHEART ECD
K060934 · MKJ
Cardiac Science Corporation
Cardiovascular · 40d
Cleared May 15, 2006
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K060989 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 35d
Cleared May 15, 2006
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K061140 · IYE
Varian Medical Systems
Radiology · 21d
Cleared May 15, 2006
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A...
K061185 · MHX
Ge Healthcare
Cardiovascular · 17d
Cleared May 15, 2006
AQUARIUSAPS SERVER
K061214 · LLZ
Terarecon,Inc.
Radiology · 13d
Cleared May 15, 2006
USGI TRANSPORT ENDOSCOPIC GUIDE
K061216 · FED
Usgi Medical
Gastroenterology & Urology · 13d
Cleared May 14, 2006
CATHASSIST
K052952 · KNY
Physician Technologies, Inc.
Gastroenterology & Urology · 206d
Cleared May 12, 2006
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
K052690 · NUJ
Suretek Medical
General & Plastic Surgery · 226d
Cleared May 12, 2006
DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS
K053191 · MVN
Innova Vision, Inc.
Ophthalmic · 178d
Cleared May 12, 2006
PARA-PRO FC50
K053257 · LKS
Alpha-Tec Systems, Inc.
Microbiology · 171d
Cleared May 12, 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040 · LPH
Zimmer, Inc.
Orthopedic · 126d
Cleared May 12, 2006
MICRUS COURIER MICROCATHETERS
K060116 · DQO
Micrus Endovascular Corporation
Cardiovascular · 115d
Cleared May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
K060323 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 92d