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

Filters: Cleared only ×
175,820 results
32761–32784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2016
McLaren Proton Therapy System
K160063 · LHN
Mclaren Health Care Corporation
Radiology · 43d
Cleared Feb 25, 2016
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
K160164 · PSZ
Becton, Dickinson & CO
Microbiology · 29d
Cleared Feb 25, 2016
Voluson S6, Voluson S8, Voluson S10
K160184 · IYN
Ge Healthcare
Radiology · 29d
Cleared Feb 25, 2016
DIVA ZSP2105CMI with QUBYX PerfectLum bundle
K160328 · PGY
The Linden Group Corp
Radiology · 20d
Cleared Feb 24, 2016
Oxyless Blood Tubing Set
K150304 · FJK
Oxyless, Ltd.
Gastroenterology & Urology · 383d
Cleared Feb 24, 2016
Strialite
K151337 · OHS
Centre Light Solutions, LLC
General & Plastic Surgery · 281d
Cleared Feb 24, 2016
Liquid CO2-2 (LCO2-2)
K152085 · KHS
Randox Laboratories, Ltd.
Chemistry · 212d
Cleared Feb 24, 2016
IV-eye
K152088 · KZA
Novarix Limited
General Hospital · 212d
Cleared Feb 24, 2016
HeartLight Deflectable Sheath
K152310 · DRA
Cardiofocus, Inc.
Cardiovascular · 194d
Cleared Feb 24, 2016
SpineView X-Pac Expandable Lumbar Cage System
K152539 · MAX
Spine View, Inc.
Orthopedic · 173d
Cleared Feb 24, 2016
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG...
K152768 · JHI
Assure Tech. Co., Ltd.
Chemistry · 153d
Cleared Feb 24, 2016
EndoChoice Water Bottle Cap System
K153588 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 70d
Cleared Feb 24, 2016
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K160161 · PSZ
Becton, Dickinson & CO
Microbiology · 28d
Cleared Feb 23, 2016
ANI Monitor
K142969 · DPS
Mdoloris Medical Systems Sas
Cardiovascular · 497d
Cleared Feb 23, 2016
Arthrex Short Suture Anchors
K151092 · MBI
Arthrex, Inc.
Orthopedic · 306d
Cleared Feb 23, 2016
twion
K151717 · ITI
Alber GmbH
Physical Medicine · 243d
Cleared Feb 23, 2016
FS-PACS
K152034 · LLZ
Ec-Web Co., Ltd.
Radiology · 216d
Cleared Feb 23, 2016
Navik 3D
K152160 · DQK
Apn Health, LLC
Cardiovascular · 204d
Cleared Feb 23, 2016
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
K152557 · NDN
G21, S.R.L.
Orthopedic · 168d
Cleared Feb 23, 2016
Spot Skan
K152831 · DXN
Skanray Technologies Private Limited
Cardiovascular · 147d
Cleared Feb 23, 2016
Palisade Pedicular Fixation System
K153323 · NKB
Spineology, Inc.
Orthopedic · 97d
Cleared Feb 23, 2016
Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control...
K153474 · DIF
Biochemical Diagnostics, Inc.
Toxicology · 83d
Cleared Feb 23, 2016
Fujifilm Video Colonoscope Model EC-600WL V2
K160196 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 27d
Cleared Feb 23, 2016
UreTron MultiProbe Lithotripter System
K160198 · FFK
Med-Sonics Corp.
Gastroenterology & Urology · 26d