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
68329–68352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2004
COCOON HYGIENIST
K040529 · EIA
Satelec
Dental · 171d
Cleared Aug 19, 2004
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
K040542 · HWC
Smith & Nephew, Inc.
Orthopedic · 170d
Cleared Aug 19, 2004
ULTRASOUND LOCALIZATION SYSTEM ULS 0142
K040741 · LNS
Hmt High Medical Technologies AG
Gastroenterology & Urology · 149d
Cleared Aug 19, 2004
BRIGHT GOLD XH
K041433 · EJS
Ivoclar Vivadent, Inc.
Dental · 83d
Cleared Aug 19, 2004
CEMENTEK
K041493 · MQV
Teknimed, S.A.
Orthopedic · 76d
Cleared Aug 19, 2004
AARHUS ANCHORAGE SYSTEM
K041527 · DZE
Medicon EG
Dental · 72d
Cleared Aug 19, 2004
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
K041610 · FJL
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 65d
Cleared Aug 19, 2004
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K041668 · NQD
Olympus America, Inc.
Chemistry · 62d
Cleared Aug 19, 2004
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
K041887 · DZL
Synthes (Usa)
Dental · 38d
Cleared Aug 19, 2004
TRI-OSTETIC
K041889 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 38d
Cleared Aug 19, 2004
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE...
K041995 · GBO
Uresil, LLC
General & Plastic Surgery · 27d
Cleared Aug 19, 2004
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
K042080 · JJX
Home Diagnostics, Inc.
Chemistry · 16d
Cleared Aug 19, 2004
SENORX INTRODUCER
K042098 · GEI
Senorx, Inc.
General & Plastic Surgery · 15d
Cleared Aug 18, 2004
WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
K040490 · DXN
Welch Allyn, Inc.
Cardiovascular · 174d
Cleared Aug 18, 2004
HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS
K040799 · DXN
Hommed, LLC
Cardiovascular · 142d
Cleared Aug 18, 2004
VENTURE WIRE CONTROL CATHETER
K040922 · DQY
Velocimed, Inc.
Cardiovascular · 132d
Cleared Aug 18, 2004
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
K041643 · CEO
Beckman Coulter, Inc.
Chemistry · 62d
Cleared Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL...
K041687 · JJX
Abbott Laboratories
Chemistry · 57d
Cleared Aug 18, 2004
OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
K041932 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 30d
Cleared Aug 18, 2004
MICROSELECTRON PDR
K041933 · JAQ
Nucletron Corp.
Radiology · 30d
Cleared Aug 18, 2004
OLYMPUS BF TYPE UC160-OL8
K042140 · ODG
Olympus Corporation
Radiology · 9d
Cleared Aug 17, 2004
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
K031152 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 494d
Cleared Aug 17, 2004
OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN...
K040108 · LYZ
Est International Corporation
General Hospital · 210d
Cleared Aug 17, 2004
SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL...
K040525 · NRJ
Sontra Medical, Inc.
General & Plastic Surgery · 169d