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

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176,076 results
65785–65808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2005
TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER
K051334 · IYN
Teratech Corp.
Radiology · 11d
Cleared Jun 02, 2005
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
K041510 · GAR
Sutures India Private Limited
General & Plastic Surgery · 360d
Cleared Jun 02, 2005
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
K041512 · GAT
Sutures India Private Limited
General & Plastic Surgery · 360d
Cleared Jun 02, 2005
EZ SMART
K043340 · NBW
Vip Diagnostics, LLC
Chemistry · 181d
Cleared Jun 02, 2005
STEALTHSTATION SYSTEM UPDATE
K050438 · HAW
Medtronic Surgical Navigation...
Neurology · 100d
Cleared Jun 02, 2005
FT FIBER OPTIC DELIVERY SYSTEMS
K050738 · GEX
Fibertech GmbH
General & Plastic Surgery · 77d
Cleared Jun 02, 2005
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P,...
K051036 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 38d
Cleared Jun 01, 2005
DIASORIN LIAISON CMV IGM/IGG
K040290 · LFZ
Diasorin S.P.A
Microbiology · 481d
Cleared Jun 01, 2005
FACEMASTER FACIAL TONING SYSTEM
K040871 · NFO
Facemaster of Beverly Hills, Inc.
Neurology · 425d
Cleared Jun 01, 2005
MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
K041897 · HAW
Schaerer Mayfield USA, Inc.
Neurology · 322d
Cleared Jun 01, 2005
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
K042297 · HCG
Acta Vascular Systems, Inc.
Neurology · 281d
Cleared Jun 01, 2005
AESKULISA TTG A AND AESKULISA TTG G
K042644 · MVM
Aesku, Inc.
Immunology · 247d
Cleared Jun 01, 2005
ZENO
K043377 · GEX
Tyrell, Inc.
General & Plastic Surgery · 175d
Cleared Jun 01, 2005
ORLUS MINI SCREW
K050568 · DZE
Ortholution Co., Ltd.
Dental · 89d
Cleared Jun 01, 2005
ABX ERYTROL
K050721 · JPK
Horiba Abx
Hematology · 72d
Cleared Jun 01, 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K050763 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 69d
Cleared Jun 01, 2005
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784 · CJM
Nichols Institute Diagnostics
Chemistry · 65d
Cleared Jun 01, 2005
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
K050925 · MQB
Shimadzu Corp.
Radiology · 49d
Cleared Jun 01, 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · GAW
United States Surgical, A Division of...
General & Plastic Surgery · 47d
Cleared Jun 01, 2005
GAMMAPLAN
K051022 · IWB
Elekta Instrument AB
Radiology · 40d
Cleared Jun 01, 2005
ONYX II FINGER PULSE OXIMETER, MODEL 9550
K051107 · DQA
Nonin Medical, Inc.
Anesthesiology · 30d
Cleared Jun 01, 2005
ARCADIS AVANTIC
K051133 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jun 01, 2005
REVOLIX AND REVOLIX JR
K051167 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 27d
Cleared Jun 01, 2005
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
K051258 · KPR
Eastman Kodak Company
Radiology · 16d