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
42265–42288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2013
TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION...
K122788 · LYY
Northstar Healthcare Holdings
General Hospital · 128d
Cleared Jan 17, 2013
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
K122951 · JAD
Icad, Inc.
Radiology · 114d
Cleared Jan 17, 2013
PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301
K123110 · GCJ
Surgical Innovations Plc
General & Plastic Surgery · 106d
Cleared Jan 17, 2013
BRIVO MR355, OPTIMA MR360
K123417 · LNH
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 72d
Cleared Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
K123612 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 55d
Cleared Jan 17, 2013
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
K123734 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 43d
Cleared Jan 17, 2013
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
K123946 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2013
MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS...
K124003 · GEX
Med-Fibers, Inc.
General & Plastic Surgery · 22d
Cleared Jan 16, 2013
OCS-B
K113246 · NPM
Nibec Company, Limited
Dental · 441d
Cleared Jan 16, 2013
NOVATION CROWN CUP LINERS
K121392 · LZO
Exactech, Inc.
Orthopedic · 252d
Cleared Jan 16, 2013
AURIGA QI
K121570 · GEX
Starmedtec GmbH
General & Plastic Surgery · 232d
Cleared Jan 16, 2013
SWISS LITHOBREAKER
K123038 · FFK
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 110d
Cleared Jan 16, 2013
DK-PTCA BALLOON CATHETER
K123264 · LOX
Intuit Medical, LLC
Cardiovascular · 90d
Cleared Jan 16, 2013
PROGASTRO SSCS ASSAY
K123274 · PCH
Gen-Probe Prodesse, Inc.
Microbiology · 89d
Cleared Jan 16, 2013
MERIT HYDROPHILIC GUIDE WIRE
K123609 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 56d
Cleared Jan 16, 2013
WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
K123671 · DRG
Sanitas, Inc.
Cardiovascular · 48d
Cleared Jan 16, 2013
PRO HMPV+ ASSAY
K123838 · OEM
Gen-Probe Prodesse, Inc.
Microbiology · 34d
Cleared Jan 16, 2013
SYNGO DYNAMICS
K123922 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Jan 15, 2013
VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS
K122873 · JOW
Caremed Supply, Inc.
Cardiovascular · 118d
Cleared Jan 15, 2013
MIRA LASERS
K123004 · GEX
Mira Lasers, LLC
General & Plastic Surgery · 110d
Cleared Jan 15, 2013
ERGO IMAGING SYSTEM
K123408 · IYX
Digirad Corp.
Radiology · 71d
Cleared Jan 15, 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · IYO
Boston Scientific Corp
Radiology · 60d
Cleared Jan 15, 2013
INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
K123788 · IYE
Varian Medical Systems, Inc.
Radiology · 36d
Cleared Jan 15, 2013
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
K123878 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 29d