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
34081–34104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2015
ML24000 UVA-1 Phototherapy Cabinet
K151795 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 70d
Cleared Sep 10, 2015
JUSHA-C23C LCD Monitor
K151861 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 64d
Cleared Sep 10, 2015
Luggie Super
K151944 · INI
Freerider Corporation
Physical Medicine · 58d
Cleared Sep 10, 2015
JUSHA-C43 LCD Monitor
K151972 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 56d
Cleared Sep 10, 2015
Stat Profile Prime ABG Analyzer System
K151982 · CHL
Nova Biomedical Corporation
Chemistry · 55d
Cleared Sep 10, 2015
ViZion DR + Wireless
K152279 · MQB
Viztek, LLC
Radiology · 29d
Cleared Sep 10, 2015
Xenco Medical Cervical Interbody System (Argus)
K152302 · ODP
Xenco Medical, LLC
Orthopedic · 27d
Cleared Sep 09, 2015
PAXgene Blood DNA Tube
K142821 · PJE
Preanalytix GmbH
Toxicology · 344d
Cleared Sep 09, 2015
NFANT Feeding Solution
K143507 · HCC
Nfant Labs, LLC
Neurology · 273d
Cleared Sep 09, 2015
U&U Sterilization Pouch and Roll
K143637 · FRG
U&U Medical Technology Co, Ltd.
General Hospital · 261d
Cleared Sep 09, 2015
TGM Biolox delta Ceramic Heads
K150576 · LZO
Tgm Medical, Inc.
Orthopedic · 187d
Cleared Sep 09, 2015
SECURE-LOOP
K151601 · MBI
Xiros, Ltd.
Orthopedic · 89d
Cleared Sep 09, 2015
Cryocare CS-3 Surgical System version 5
K151968 · GEH
Healthtronics
General & Plastic Surgery · 55d
Cleared Sep 09, 2015
VAPRO PLUS POCKET Intermittent Catheter
K152268 · GBM
Hollister Incorporated
Gastroenterology & Urology · 29d
Cleared Sep 09, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine...
K152269 · DKZ
Healgen Scientific, LLC
Toxicology · 29d
Cleared Sep 08, 2015
CAREVIEW 1800R
K141488 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 460d
Cleared CT Sep 08, 2015
Fully Automatic Electronic Blood Pressure Monitor
K151460 · DXN
Andon Health Co, Ltd.
Cardiovascular · 99d
Cleared Sep 08, 2015
S-scan
K151668 · LNH
Esaote, S.P.A.
Radiology · 81d
Cleared Sep 08, 2015
LigaSure Curved, Small Jaw, Open Sealer/Divider
K152286 · GEI
Covidien
General & Plastic Surgery · 26d
Cleared Sep 05, 2015
On Call Express Pro Blood Glucose Monitoring System
K151595 · NBW
ACON Laboratories, Inc.
Chemistry · 85d
Cleared Sep 04, 2015
Navigated XIA 4.5 Polyaxial Screwdriver
K143597 · OLO
Stryker Corporate
Orthopedic · 260d
Cleared Sep 04, 2015
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
K143653 · OCC
Nanosphere, Inc.
Microbiology · 255d
Cleared Sep 04, 2015
Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
K150064 · MQV
Orthogem, Ltd.
Orthopedic · 234d
Cleared Sep 04, 2015
Volcano Visions PV .018 Digital IVUS Catheter
K150442 · OBJ
Volcano Corporation
Cardiovascular · 196d