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
34201–34224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2015
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS...
K143701 · OBJ
Volcano Corporation
Cardiovascular · 245d
Cleared Aug 26, 2015
GDH Professional Blood Glucose Monitoring System and GDH Professional LED...
K150274 · NBW
Infopia Co, Ltd.
Chemistry · 203d
Cleared Aug 26, 2015
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
K150658 · DFH
The Binding Site Group , Ltd.
Immunology · 166d
Cleared Aug 26, 2015
EDLENi Intra-Oral Sensor
K150823 · MUH
Edlen Imaging, LLC
Radiology · 152d
Cleared Aug 26, 2015
LINK® MEGASYSTEM-C®
K151008 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 133d
Cleared Aug 26, 2015
BioZorb LP Marker
K152070 · NEU
Focal Therapeutics
General & Plastic Surgery · 30d
Cleared Aug 26, 2015
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery...
K152071 · MQV
Novabone Products, LLC
Orthopedic · 30d
Cleared Aug 26, 2015
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
K152076 · GWO
Stryker
Neurology · 30d
Cleared Aug 26, 2015
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
K152081 · FZP
Teleflexmedical, Inc.
General & Plastic Surgery · 30d
Cleared Aug 26, 2015
S9 Portable Digital Color Doppler Ultrasound System
K152165 · IYN
Sonoscape Medical Corp.
Radiology · 23d
Cleared Aug 25, 2015
25-Hydroxy Vitamin Ds EIA
K142351 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 368d
Cleared Aug 25, 2015
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
K142760 · MQX
K.S. Choi Corporation
General Hospital · 334d
Cleared Aug 25, 2015
BD MAX Enteric Parasite Panel, BD MAX Instrument
K143648 · PCH
Becton, Dickinson and Company
Microbiology · 246d
Cleared Aug 25, 2015
Zekang Self-adhesive Electrode
K150971 · GXY
Jiangsu Zekang Medical Technology...
Neurology · 134d
Cleared Aug 25, 2015
BioGuard Air/Water Valve, BioGuard Suction Valve
K151345 · ODC
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 98d
Cleared Aug 25, 2015
Nuocande Plastic Manual Wheelchair Model NKD L07
K151797 · IOR
Ningbo Lecount Medical Technology...
Physical Medicine · 54d
Cleared Aug 25, 2015
Retraction Aspirator
K152097 · QEW
Inari Medical
Cardiovascular · 28d
Cleared Aug 24, 2015
LED Curing Light
K150205 · EBZ
Monitex Industrial Co., Ltd.
Dental · 207d
Cleared Aug 24, 2015
Skynector CPAP Mask
K150685 · BZD
Sky Wise Medical Instrument (Shen...
Anesthesiology · 160d
Cleared Aug 24, 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K151343 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 97d
Cleared Aug 21, 2015
BC-3600 Auto Hematology Analyzer
K143348 · GKZ
Mindray Bio-Medical Electronics Co.,...
Hematology · 273d
Cleared Aug 21, 2015
SynePure Wound Cleanser
K143444 · FRO
Synedgen, Inc.
General & Plastic Surgery · 262d
Cleared Aug 21, 2015
Lifelines iEEG
K143487 · OLT
Kvikna Ehf
Neurology · 256d
Cleared Aug 21, 2015
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal...
K143529 · NUC
Medline Industries, Inc.
Obstetrics & Gynecology · 252d