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
66505–66528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2005
INTEGRA BONE FIXATION SYSTEM
K050492 · HRS
Integra Lifesciences Corp.
Orthopedic · 14d
Cleared Mar 14, 2005
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050501 · FGE
Abbott Vascular Devices
Gastroenterology & Urology · 14d
Cleared Mar 11, 2005
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT
K041825 · JWH
Smith & Nephew, Inc.
Orthopedic · 247d
Cleared Mar 11, 2005
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL...
K042556 · BTM
Enter Medical Corporation
Anesthesiology · 172d
Cleared Mar 11, 2005
BODYGUARD INFUSION PUMP SYSTEM
K042696 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 162d
Cleared Mar 11, 2005
UNDER BUTTOCKS DRAPE
K042893 · KKX
International Medsurg Connection, Inc.
General Hospital · 143d
Cleared Mar 11, 2005
VISION
K042956 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Mar 11, 2005
HARVEST GRAFT DELIVERY SYRINGE
K043261 · FMF
Harvest Technologies, Corp.
General Hospital · 107d
Cleared Mar 11, 2005
ONLINE DAT PROPOXYPHENE PLUS
K043303 · JXN
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Mar 11, 2005
MODIFICATION TO DYNESYS SPINAL SYSTEM
K043565 · NQP
Zimmer Spine, Inc.
Orthopedic · 74d
Cleared Mar 11, 2005
ON CALL MULTI-DRUG HOME TEST
K050050 · LDJ
ACON Laboratories, Inc.
Toxicology · 60d
Cleared Mar 11, 2005
NITRILE POWDERED EXAMINATION GLOVES (WHITE)
K050215 · LZA
Hartalega Sdn Bhd
General Hospital · 39d
Cleared Mar 11, 2005
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
K050232 · PID
Boston Scientific Corp
Gastroenterology & Urology · 38d
Cleared Mar 11, 2005
LYSUS INFUSION SYSTEM
K050472 · DRA
Ekos Corp.
Cardiovascular · 15d
Cleared Mar 11, 2005
INNOVA 2100
K050489 · OWB
Ge Medical Systems, LLC
Radiology · 14d
Cleared Mar 10, 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K040751 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 351d
Cleared Mar 10, 2005
RELIANT LASER II SYSTEM AND ACCESSORIES
K042319 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 196d
Cleared Mar 10, 2005
PRE-POWDERED VINYL EXAM GLOVES
K042951 · LYZ
Zibo Hengchang Plastic & Rubber...
General Hospital · 135d
Cleared Mar 10, 2005
VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE
K042952 · LYZ
Zibo Hengchang Plastic & Rubber...
General Hospital · 135d
Cleared Mar 10, 2005
HYPERQ SYSTEM
K042981 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 132d
Cleared Mar 10, 2005
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
K043526 · LGF
Noble Fiber Technologies, Inc.
Orthopedic · 79d
Cleared Mar 10, 2005
ENDOLINK TRUE MOVEMENT SYSTEM
K043541 · GCJ
Novare Surgical Systems, Inc.
General & Plastic Surgery · 78d
Cleared Mar 10, 2005
HEMOSIL D-DIMER
K050278 · DAP
Instrumentation Laboratory CO
Hematology · 31d
Cleared Mar 10, 2005
TSX-201A AQUILION LB CT SCANNER
K050458 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d