23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLASMA SPRAYED SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
TruForm
FDA UDI
Rmo, Inc.·00885797099860·MN 2ND BI BD KT N/L R/L 176
TruForm
FDA UDI
Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085022574·10% Formalin, Microvials 64 vials
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
FDA 510(k)
FDA Class 2
·Neurology
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Zimmer, Inc.·00889024066441·
2520274-2013-10934
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MNI·February 28, 2013
PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 1, 2011
HEARTSTREAM XL
FDA Adverse Event
Malfunction
·AGILENT TECHNOLOGIES, INC.·Product code MKJ·February 27, 2008
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·June 14, 2011
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
PROFILE 3D
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021
TMJ SYSTEM CROSS DRIVE FOSSA SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·June 1, 2018
"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 1, 2018
TMJ SYSTEM CROSS DRIVE FOSSA SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·June 1, 2018
"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 1, 2018
"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 1, 2018