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
46297–46320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
K112007 · DQK
Biosense Webster, Inc.
Cardiovascular · 83d
Cleared Oct 05, 2011
SPEACELABS MULTIGAS MODULE
K112173 · CBR
Spacelabs Healthcare
Anesthesiology · 69d
Cleared Oct 05, 2011
CANDELA GENTLEMAX FAMILY OF LASERS
K112715 · GEX
Candela Corp.
General & Plastic Surgery · 16d
Cleared Oct 04, 2011
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · LCX
Taidoc Technology Corporation
Chemistry · 312d
Cleared Oct 04, 2011
CARDIOMED
K103651 · LDD
Cardio Medical Products, Inc.
Cardiovascular · 294d
Cleared Oct 04, 2011
SOVEREIGN SPINAL SYSTEM
K110063 · OVD
Medtronic Sofamor Danek, Inc.
Orthopedic · 267d
Cleared Oct 04, 2011
APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K110870 · IYN
Toshiba America Medical Systems, In.C
Radiology · 189d
Cleared Oct 04, 2011
TECO DIAGNOSTICS SALIVA ALCOHOL TEST
K111206 · DIC
Teco Diagnostics
Chemistry · 158d
Cleared Oct 04, 2011
OXIMETRY INTERFACE KIT
K111378 · MNS
Philips Respironics, Inc.
Anesthesiology · 140d
Cleared Oct 04, 2011
OEC(R) 9800, OEC(R) 9800 PLUS
K111551 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 123d
Cleared Oct 04, 2011
FLAATZ 560
K111583 · MQB
Drtech Corp.
Radiology · 119d
Cleared Oct 04, 2011
VENOTRAIN CURAFLOW
K111662 · DWL
Bauerfeind AG
General Hospital · 112d
Cleared Oct 04, 2011
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL...
K111905 · DXJ
Philips Medizinsysteme Boeblingen...
Cardiovascular · 91d
Cleared Oct 04, 2011
DIGITAL CLINICAL THERMOMETER MODEL V901US
K112116 · FLL
Amperor-Electronic(Sz) Co., Ltd.
General Hospital · 71d
Cleared Oct 04, 2011
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
K112456 · GCJ
Teleflexmedical, Inc.
General & Plastic Surgery · 40d
Cleared Oct 04, 2011
SHAKER DIGITAL THERMOMETER
K112703 · FLL
Measure Technology Co. , Ltd.
General Hospital · 18d
Cleared Oct 03, 2011
SILVER CARE ANITBACTERIAL TOOTHBRUSH
K102871 · EFW
Piave Spazzolificio S.P.A.
Dental · 368d
Cleared Oct 03, 2011
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K103675 · LZA
Chienmax Vietnam Co., Ltd.
General Hospital · 291d
Cleared Oct 03, 2011
PROSTHETIC SYSTEM
K110308 · NHA
Osstem Implant Co., Ltd.
Dental · 243d
Cleared Oct 03, 2011
EXCELLAGEN
K110318 · KGN
Tissue Repair Company
General & Plastic Surgery · 243d
Cleared Oct 03, 2011
ETWO SKIN TREATMENT SYSTEM
K110672 · GEI
Syneron, Ltd.
General & Plastic Surgery · 208d
Cleared Oct 03, 2011
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM,...
K111169 · DZB
Kwang Myung Daicom, Inc.
Dental · 160d
Cleared Oct 03, 2011
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
K111357 · DZE
Straumann USA
Dental · 140d
Cleared Oct 03, 2011
PINNACLE PRECISION ACCESS SYSTEM
K111606 · DYB
Terumo Medical Corp.
Cardiovascular · 116d