17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOTEQUE VAGINAL PESSARIES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HANISCH MEDICAL
FDA UDI
Hanisch Medical Ltda·07901089807029·H52-LID F/INST.STANDER---BLUE
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478028·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478004·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478011·
5013289
FDA Adverse Event
Malfunction
·August 19, 2015
EXCELSIOR MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code DQY·April 13, 2010
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
FDA 510(k)
FDA Class 2
·Immunology
EXCELSIOR MICROCATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code DQY·May 18, 2010
EXCELSIOR MICROCATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DQY·August 2, 2010
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 20, 2013
NEXGEN FEMORAL IMPACTOR/EXTRACTOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·March 8, 2011
E500
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·March 14, 2008
MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·May 12, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012