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
68737–68760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2004
EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER
K041416 · EYC
Deroyal
Gastroenterology & Urology · 36d
Cleared Jul 02, 2004
NXSTAGE SYSTEM ONE
K041424 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 35d
Cleared Jul 02, 2004
GE VIVID 7 BT04
K041552 · IYN
General Electric Co.
Radiology · 23d
Cleared Jul 02, 2004
STOCKERTIR PURGE CONTROL (APC) SYSTEM
K041558 · DTW
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared Jul 02, 2004
SOURCELINK
K041576 · KXK
C.R. Bard, Inc.
Radiology · 21d
Cleared Jul 02, 2004
H&S-CONDUCTIVITY STANDARD SOLUTION
K041636 · FKH
H & S Technical Services
Gastroenterology & Urology · 15d
Cleared Jul 01, 2004
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
K022823 · MGZ
Geister Medizin Technik GmbH
Cardiovascular · 675d
Cleared Jul 01, 2004
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
K032937 · DXX
Stereotaxis, Inc.
Cardiovascular · 283d
Cleared Jul 01, 2004
ORTHOPEDIC ALLIANCE SPINE SYSTEM
K033826 · MNI
Orthopedic Alliance, LLC
Orthopedic · 204d
Cleared Jul 01, 2004
RADIX CERVICAL PLATE
K033951 · KWQ
Pisharodi Surgicals, Inc.
Orthopedic · 192d
Cleared Jul 01, 2004
LPS
K033959 · JWH
Depuy, Inc.
Orthopedic · 192d
Cleared Jul 01, 2004
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
K040096 · KWP
Spinal Concepts, Inc.
Orthopedic · 163d
Cleared Jul 01, 2004
PERIPHERAL CUTTING BALLOON
K040155 · PNO
Boston Scientific Corp
Cardiovascular · 160d
Cleared Jul 01, 2004
POWERHEART AED G3A
K040438 · MKJ
Cardiac Science, Inc.
Cardiovascular · 133d
Cleared Jul 01, 2004
MICROMESAM BASIC-SET
K040576 · MNR
Map Medizintechnik Fur Arzt Und...
Anesthesiology · 119d
Cleared Jul 01, 2004
ARTHREX SMALL FRAGMENT PLATES AND SCREWS
K040907 · HRS
Arthrex, Inc.
Orthopedic · 85d
Cleared Jul 01, 2004
EASYNET BODY POSITION MODULE
K040932 · LEL
Cadwell Laboratories, Inc.
Neurology · 83d
Cleared Jul 01, 2004
RADIAL NAIL SYSTEM
K040938 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 80d
Cleared Jul 01, 2004
ANKYLOS DENTAL IMPLANT SYSTEM
K040946 · DZE
Friadent GmbH
Dental · 80d
Cleared Jul 01, 2004
CADWELL LIMB MOVEMENT MODULE
K040986 · LEL
Cadwell Laboratories, Inc.
Neurology · 77d
Cleared Jul 01, 2004
OMEGA 2 SYSTEM
K041001 · KTT
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Jul 01, 2004
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
K041081 · KTT
Hand Innovations, Inc.
Orthopedic · 66d
Cleared Jul 01, 2004
FAST START TENS, MODEL FS 3001
K041092 · GZJ
Vision Quest Industries, Inc.
Neurology · 66d
Cleared Jul 01, 2004
REVISION KNEE SYSTEM
K041106 · JWH
Smith & Nephew, Inc.
Orthopedic · 64d