16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The Small PLATEAU (PLATEAU-C) Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515023338·Bergman-Forester Sponge Fcps, cvd, 9 1/2" (24cm)
Orthocryl®
FDA UDI
DENTAURUM GmbH & Co.KG·J011161127000·Orthocryl® liquid, red/ orthodontic acrylics
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
FDA 510(k)
FDA Class 2
·Cardiovascular
PATIENT MONITOR, MODEL PM50
FDA 510(k)
FDA Class 2
·Cardiovascular
MOSAIC
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·March 12, 2019
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·May 27, 2020
OLYMPUS ENDOSCOPE REPROCESSOR
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FEB·July 6, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
CG COMPOSITE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 16, 2023
CG COMPOSITE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·February 8, 2023
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014