17 results
·
28ms
·
Sources: EU EUDAMED, US FDA
BRILLIANT GREEN AGAR
FDA 510(k)
FDA Class 1
·Microbiology
ERA® Micro Ovd. Males Red (5)
FDA UDI
STERNGOLD DENTAL LLC·00841549100840·Attachments are two-part connectors. One part ...
AURADONICS
FDA UDI
AURADONICS INC.·00810033835391·LATEX ELASTICS 1/8" 6.5 oz. - NEON, 10000 ea., ...
Bioplate®
FDA UDI
Bioplate, Inc.·M3848110410·BioMesh® 3MC - 90 x 120 mm
MINI VARIABLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WATERLASE, MILLENNIUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 15, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 5, 2021
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 28, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 26, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
CLARITY DDDR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·October 31, 2012
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 10, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·December 9, 2011
STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
FDA Adverse Event
Injury
·Product code FTM·July 12, 2022
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 30, 2013
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015