15 results · 22ms · Sources: EU EUDAMED, US FDA

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BARD ELIMINATOR PET BALLOON DILATORS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033936·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...

PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING

FDA 510(k)
FDA Class 2 ·Radiology

SILVERLEAF CONTACT WOUND DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

R90 SPACERS

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MQP·October 9, 2009

R90 SPACERS

FDA Adverse Event
Other ·WARSAW ORTHOPEDIC INC·Product code MAX·November 6, 2009

R90 SPACERS

FDA Adverse Event
Injury ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·December 21, 2009

PORTASCAN

FDA Adverse Event
Malfunction ·MEDIWATCH UK LTD·Product code ITX·November 17, 2011

ICL (IMPLANTABLE COLLAMER LENS)

FDA Adverse Event
Injury ·STAAR SURGICAL COMPANY·Product code MTA·April 3, 2013

CONTOUR TEST STRIPS

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·March 23, 2011

SIGMA HP UNI TIB TRAY SZ2 RMLL

FDA Adverse Event
Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code HRY·April 24, 2008

R90 SPACER

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code NKB·August 5, 2011

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018