18 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CURITY SURGICAL SCRUB BRUSH SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ultraverse® 018
FDA UDI
Bard Peripheral Vascular, Inc.·00801741165115·Ultraverse® 018 PTA Balloon Dilatation Catheter...
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·CIBATINT(TM) TINTING PROCESS
CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
FDA 510(k)
FDA Class 2
·Cardiovascular
RMS 111F RESPIRATORY MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·CIBATINT(TM) TINTING PROCESS
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 14, 2014
ENDEAVOR SPRINT RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·November 6, 2012
TALENT ABDOMINAL AUI STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 24, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021