15 results
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29ms
·
Sources: EU EUDAMED, US FDA
Cardinal Health NPWT PRO HC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490542395·TREPHINE BASE CASE
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120502·Guidewire 1.2x150mm Dbl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120519·Guidewire 1.2x150mm Sgl Trocar
POROUS COATED ACETABULAR COMPONENTS
FDA 510(k)
FDA Class 3
·Orthopedic
FASTX STERNAL INTRAOSSEOUS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
FREESTYLE LIBRE 3 PLUS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QBJ·May 9, 2026
LINER: DM DOUBLE MOBILITY HC LINER 28/DMD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code MEH·July 31, 2015
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015
AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTP·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
LINOX SD 75/18
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code LWS·August 29, 2008
Verza Guidance System
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436118740·Ultrasound guide for use with VerzaLink™ enable...
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code FQH·January 24, 2019
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024