FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37897–37920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2014
GIBRALT ROD-TO-ROD CROSS CONNECTORS
K140645 · KWP
Exactech Sarasota
Orthopedic · 29d
Cleared Apr 11, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
K140646 · MQB
Rayence Co., Ltd.
Radiology · 29d
Cleared Apr 10, 2014
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
K131028 · EOQ
Pentax Medical Company
Ear, Nose, Throat · 363d
Cleared Apr 10, 2014
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
K131902 · FDS
Pentax Medical Company
Gastroenterology & Urology · 289d
Cleared Apr 10, 2014
IEEG
K131944 · OMC
Jordan Neuroscience, Inc.
Neurology · 287d
Cleared Apr 10, 2014
ONTEX AND OTHERS PROPRIETARY NAMES
K132208 · HIL
Ontex Bvba
Obstetrics & Gynecology · 268d
Cleared Apr 10, 2014
VECTRA NEO CLINICAL THERAPY SYSTEM
K132284 · IPF
Djo, LLC
Physical Medicine · 261d
Cleared Apr 10, 2014
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
K132290 · PBF
Materialise NV
Orthopedic · 261d
Cleared Apr 10, 2014
RETROMTA-ORTHOMTA II
K132825 · KIF
Biomta
Dental · 213d
Cleared Apr 10, 2014
MULTIX SELECT DR
K132934 · KPR
Siemens Medi Cal Solutions, Inc.
Radiology · 204d
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