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
39649–39672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 2013
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
K131591 · HWC
Pega Medical, Inc.
Orthopedic · 180d
Cleared Nov 27, 2013
SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR
K132201 · LYZ
Zibo Intco Medical Products Co., Ltd.
General Hospital · 134d
Cleared Nov 27, 2013
MYLABSEVEN, MYLABALPHA
K132231 · IYN
Esaote, S.P.A.
Radiology · 132d
Cleared Nov 27, 2013
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON...
K132658 · FZP
Teleflex Medical
General & Plastic Surgery · 93d
Cleared Nov 27, 2013
E-CUBE 7
K132687 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 91d
Cleared Nov 27, 2013
ESPIN SYSTEM
K133061 · HRX
Nlt Spine, Ltd.
Orthopedic · 61d
Cleared Nov 27, 2013
TITLE 2 POLYAXIAL SPINAL SYSTEM
K133086 · NKB
Zimmer Spine, Inc.
Orthopedic · 58d
Cleared Nov 27, 2013
ZIP MIS INTERSPINOUS FUSION SYSTEM
K133091 · PEK
Aurora Spine
Orthopedic · 58d
Cleared Nov 27, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K133282 · KRD
Reverse Medical Corporation
Cardiovascular · 33d
Cleared Nov 27, 2013
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
K133329 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Nov 26, 2013
SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
K122024 · FRC
Spsmedical Supply Corp.
General Hospital · 503d
Cleared Nov 26, 2013
PRODIGY CHOICE
K122340 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 481d
Cleared Nov 26, 2013
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · HSD
Exactech, Inc.
Orthopedic · 204d
Cleared Nov 26, 2013
SOLAX
K131302 · INI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 203d
Cleared Nov 26, 2013
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K131369 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 26, 2013
NEURODYN MULTIWAVE, AUSSIE SPORT
K131629 · IPF
Ibramed Equipamentos Medicos
Physical Medicine · 175d
Cleared Nov 26, 2013
DISPOSABLE INFUSION SET
K131646 · LHI
Shanghai Jinta Medical Co., Ltd.
General Hospital · 174d
Cleared Nov 26, 2013
EMOTION ECG MOBILE
K131699 · DXH
Mega Electronics , Ltd.
Cardiovascular · 168d
Cleared Nov 26, 2013
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
K131828 · LYZ
Jiangsu Handsafe Glove Co., Ltd.
General Hospital · 159d
Cleared Nov 26, 2013
CV3000 HOLTER ANALYSIS SYSTEM
K131897 · MLO
Vales & Hills Biomedical Tech. , Ltd.
Cardiovascular · 154d
Cleared Nov 26, 2013
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS...
K131913 · DRG
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 153d
Cleared Nov 26, 2013
NEWTRON BOOSTER
K131997 · ELC
Satelec - Acteon Group
Dental · 151d
Cleared Nov 26, 2013
ASPIRE RX-LP6 ASPIRATION CATHETER
K131998 · QEZ
Control Medical Technology, LLC
Cardiovascular · 151d
Cleared Nov 26, 2013
SHASER V-MINI RX
K132170 · ONF
Shaser, Inc.
General & Plastic Surgery · 134d