18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Accurett
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK116151·DD tempMED are pre-colored dental milling blank...
OsteoMed
FDA UDI
OSTEOMED LLC·00842528102183·#15 Self-Retaining Cannulated Driver, Standard ...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111379086·S E MAYO DISS SCISS CVD 9 TC
POWERWIRE RADIOFREQUENCY GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERDRY TEXTILE WITH SILVER
FDA 510(k)
FDA Class 1
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014
TRACTION MACHINE - ME 4000
FDA Adverse Event
Malfunction
·METTLER ELECTRONICS CORP·Product code ITH·June 5, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 6, 2021
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 7, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2020
VENT RES TR SAL-RIC ST BA
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·November 26, 2024
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020
LZOVERSAFITCUP CC TRIO NO HOLE CUP
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 3, 2019
MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 29, 2018
BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 11, 2019
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017