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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
38497–38520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2014
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
K133045 · NBW
Infopia Co, Ltd.
Chemistry · 195d
Cleared Apr 10, 2014
CONTOUR I V3.1 SYSTEM
K133238 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 171d
Cleared Apr 10, 2014
REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
K133578 · NUJ
Stryker Sustainability Solutions
General & Plastic Surgery · 140d
Cleared Apr 10, 2014
BIO-PROBE TRANSDUCER (ADULT)
K133903 · DPT
Medtronic, Inc.
Cardiovascular · 111d
Cleared Apr 10, 2014
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
K140042 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 92d
Cleared Apr 10, 2014
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K140339 · MWI
Covidien
Cardiovascular · 59d
Cleared Apr 10, 2014
DUALGUARD
K140473 · CCK
Flexicare Medical, Ltd.
Anesthesiology · 44d
Cleared Apr 10, 2014
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
K140648 · JIT
Tosoh Bioscience, Inc.
Chemistry · 28d
Cleared Apr 10, 2014
STREAMLINE TL SPINAL FIXATION SYSTEM
K140696 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 22d
Cleared Apr 09, 2014
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
K123555 · KNT
Covidien
Gastroenterology & Urology · 506d
Cleared Apr 09, 2014
EMERGENCY PORTABLE VENTILATOR
K131098 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 356d
Cleared Apr 09, 2014
SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
K131563 · GDW
Opus Ksd, Inc.
General & Plastic Surgery · 314d
Cleared Apr 09, 2014
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
K131855 · FDF
Pentax Medical Company
Gastroenterology & Urology · 292d
Cleared Apr 09, 2014
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
K132009 · EOB
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 282d
Cleared Apr 09, 2014
MEGA ISQ
K132401 · EKX
Osstell AB
Dental · 251d
Cleared Apr 09, 2014
HTFX-222
K133182 · EBF
GC America, Inc.
Dental · 174d
Cleared CT Apr 09, 2014
ZELTIQ COOLSCULPTING SYSTEM
K133212 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 173d
Cleared Apr 09, 2014
STRYKER TEMPORARY CONDYLAR PROSTHESIS
K133285 · NEI
Stryker
Dental · 166d
Cleared Apr 09, 2014
TRC-PASTE
K133716 · KIF
Km Corporation
Dental · 125d
Cleared Apr 09, 2014
VIORA V-TOTAL
K133837 · GEX
Viora , Ltd.
General & Plastic Surgery · 112d
Cleared Apr 09, 2014
MD-FLEX HEAVY BODY
K134008 · ELW
Meta Biomed, Inc.
Dental · 100d
Cleared Apr 09, 2014
LEXICONTURE MECHANICAL DILATOR SHEATH SET
K140047 · DRE
Spectranetics Corp.
Cardiovascular · 90d
Cleared Apr 09, 2014
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE...
K140609 · GDW
Covidien
General & Plastic Surgery · 30d
Cleared Apr 08, 2014
FLIGHT 60 VENTILATOR
K130171 · CBK
Flight Medical Innovations , Ltd.
Anesthesiology · 439d