47 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CART, MODE NUMBER UDS-CART
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
P.F.C. SIGMA RPF
FDA UDI
DEPUY (IRELAND)·10603295224044·P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 5 LEFT
HEMOCHRON SIGNATURE ELITE
FDA 510(k)
FDA Class 2
·Hematology
Vertessa Lite
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NexGen®
FDA UDI
Zimmer, Inc.·00889024207011·
NexGen®
FDA UDI
Zimmer, Inc.·00889024207028·
NexGen®
FDA UDI
Zimmer, Inc.·00889024207042·
NexGen®
FDA UDI
Zimmer, Inc.·00889024207035·
LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX PRECOAT FEMORAL G-L LPS-FLEX PRECOAT FEMORAL G-R LPS-FLEX PRECOAT FEMORAL H-L LPS-FLEX PRECOAT FEMORAL H-R¿ LPS-FLEX POROUS FEMORAL E-R This device is indicated for patients with severe knee pain and disability¿
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX PCT FEM F-L MINUS CR-FLEX PCT FEM F-R MINUS CR-FLEX PCT FEM G-L MINUS CR-FLEX PCT FEM G-R MINUS This device is indicated for patients with severe knee pain and disability
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R CR-FLEX PCT FEM F-L CR-FLEX PCT FEM F-R CR-FLEX PCT FEM G-L CR-FLEX PCT FEM G-R This device is indicated for patients with severe knee pain and disability
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
AXIUM 3-D DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·February 8, 2013
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 22, 2014
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 6, 2011
TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code EWY·May 16, 2023
TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code EWY·March 22, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·June 5, 2023
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·June 16, 2023
TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code EWY·February 15, 2023