22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983070·posteriors; shade B4; size S; upper jaw
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
FDA 510(k)
FDA Class 2
·Cardiovascular
TOGGLELOC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·December 3, 2014
NAVIGATION STEALTHSTATION TOOL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code OLO·September 27, 2018
NA
FDA UDI
Zimmer, Inc.·00889024218666·
NA
FDA UDI
Zimmer, Inc.·00889024218703·
NA
FDA UDI
Zimmer, Inc.·00889024218680·
NA
FDA UDI
Zimmer, Inc.·00889024218710·
NA
FDA UDI
Zimmer, Inc.·00889024218727·
NA
FDA UDI
Zimmer, Inc.·00889024218673·
NA
FDA UDI
Zimmer, Inc.·00889024218697·
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·February 28, 2013
NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·August 6, 2014
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·February 4, 2011
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 26, 2015