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
55129–55152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2008
DPL THERAPY SYSTEM
K081570 · ILY
Led Technologies, LLC
Physical Medicine · 156d
Cleared Nov 07, 2008
ENTERAL PUMP SET, MODEL 20-1010
K081725 · KNT
Viasys Medsystems
Gastroenterology & Urology · 142d
Cleared Nov 07, 2008
IDI IMPLANT SYSTEM
K081806 · DZE
Idi Biomedical, LLC
Dental · 134d
Cleared Nov 07, 2008
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
K082056 · FFX
Life-Tech, Inc.
Gastroenterology & Urology · 109d
Cleared Nov 07, 2008
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066 · HFE
Cook Urological, Inc.
Obstetrics & Gynecology · 108d
Cleared Nov 07, 2008
SYNTHES (USA) 3.5MM LCP HOOK PLATE
K082072 · HRS
Synthes (Usa)
Orthopedic · 108d
Cleared Nov 07, 2008
NOX T3, NOXTURNAL (PC APPLICATION)
K082113 · MNR
Nox Medical
Anesthesiology · 102d
Cleared Nov 07, 2008
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
K082243 · OWB
General Medical Merate S.P.A
Radiology · 92d
Cleared Nov 07, 2008
DIGITAL CLINICAL THERMOMETER MODEL V9XX
K082266 · FLL
Amperor-Electronic(Sz) Co., Ltd.
General Hospital · 88d
Cleared Nov 07, 2008
HEALIX TI ANCHOR
K082282 · HWC
Depuy Mitek, A Johnson & Johnson Co.
Orthopedic · 88d
Cleared Nov 07, 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 81d
Cleared Nov 07, 2008
SYNGO MR B17
K082427 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Nov 07, 2008
MICROMYST APPLICATOR, MODEL 20-5000
K082454 · FMF
Covidien
General Hospital · 73d
Cleared Nov 07, 2008
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC...
K082475 · DSI
Medtronic, Inc.
Cardiovascular · 71d
Cleared Nov 07, 2008
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
K082512 · NDC
Dimensional Dosing Systems, Inc.
General Hospital · 70d
Cleared Nov 07, 2008
SILS PORT, MODELS SILSPT5, SILSPT12
K082619 · GCJ
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 59d
Cleared Nov 07, 2008
MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL
K082627 · IZL
Minxray, Inc.
Radiology · 59d
Cleared Nov 07, 2008
ONCENTRA RT VIEWER 1.0
K082642 · MUJ
Nucletron Corporation
Radiology · 57d
Cleared Nov 07, 2008
PRO HMPV+ ASSAY
K082688 · OEM
Prodesse, Inc.
Microbiology · 53d
Cleared Nov 07, 2008
MYSTIQUE MB CERAMIC BRACKETS
K082974 · NJM
Dentsply Interntional
Dental · 32d
Cleared Nov 07, 2008
SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM
K083141 · NHA
Simpact, LLC
Dental · 15d
Cleared Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
K083148 · DRX
Bio Protech, Inc.
Cardiovascular · 14d
Cleared Nov 07, 2008
1.5T ATLAS SPEEDER HEAD-NECK COIL
K083160 · MOS
Quality Electrodynamics
Radiology · 11d
Cleared Nov 06, 2008
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
K080613 · OCT
Minimally Invasive Devices, LLC
Gastroenterology & Urology · 247d