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
52969–52992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2009
CODMAN ISOCOOL BIPOLAR FORCEPS
K083895 · GEI
Codman & Shurtleff, Inc.
General & Plastic Surgery · 176d
Cleared Jun 23, 2009
JIAJIAN SELF-ADHESIVE ELECTRODE
K090198 · GXY
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 147d
Cleared Jun 23, 2009
ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
K090375 · OLO
Aesculap Implant System, Inc.
Orthopedic · 126d
Cleared Jun 23, 2009
ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS,...
K090393 · GEI
Arthrocare Corp.
General & Plastic Surgery · 126d
Cleared Jun 23, 2009
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO...
K090404 · NBW
Taidoc Technology Corporation
Chemistry · 126d
Cleared Jun 23, 2009
AXXENT FLEXISHIELD MINI
K090417 · IXI
Xoft, Inc.
Radiology · 125d
Cleared Jun 23, 2009
BRILLIANCE DUAL ENERGY OPTION
K090462 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 120d
Cleared Jun 23, 2009
VISION TOOLS
K090668 · LLZ
Millensys
Radiology · 102d
Cleared Jun 23, 2009
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
K091055 · IKT
Rhythmlink International, LLC
Neurology · 71d
Cleared Jun 23, 2009
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
K091056 · IKT
Rhythmlink International, LLC
Neurology · 71d
Cleared Jun 23, 2009
PORTALVISION ADVANCED IMAGING
K091209 · IYE
Varian Medical Systems, Inc.
Radiology · 60d
Cleared Jun 23, 2009
VINYL POWDERED EXAMINATION GLOVE
K091427 · LYZ
Shun DA (Xinghua) Co., Ltd.
General Hospital · 41d
Cleared Jun 23, 2009
CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
K091549 · MBI
Linvatec Corp.
Orthopedic · 27d
Cleared Jun 22, 2009
VIDAS CA 15-3 ASSAY
K080469 · LTK
bioMerieux, Inc.
Immunology · 487d
Cleared Jun 22, 2009
ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
K083580 · ILY
Led Intellectual Properties, LLC
Physical Medicine · 201d
Cleared Jun 22, 2009
LAMBDA LIGHT CHAINS
K083601 · DEH
SENTINEL CH. SpA
Immunology · 199d
Cleared Jun 22, 2009
DEXIS SOFTWARE
K090431 · LLZ
Dexis, LLC
Radiology · 123d
Cleared Jun 22, 2009
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR
K090835 · MAI
Linvatec Corp.
Orthopedic · 87d
Cleared Jun 22, 2009
MICROPLEX COIL SYSTEM-COSMOS
K090891 · HCG
MicroVention, Inc.
Neurology · 84d
Cleared Jun 22, 2009
CERNER PROVISION WORKSTATION (VERSION 2.5)
K091032 · LLZ
Cerner Corp.
Radiology · 73d
Cleared Jun 22, 2009
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
K091593 · QEZ
Possis Medical, Inc.
Cardiovascular · 20d
Cleared Jun 22, 2009
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K091636 · MTJ
Ceremed , Inc.
General & Plastic Surgery · 18d
Cleared Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE...
K082340 · CGN
Roche Diagnostics Corp.
Chemistry · 308d
Cleared Jun 19, 2009
MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM
K082843 · DZE
Dentis Co., Ltd.
Dental · 263d