24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SeaSpine® Shoreline ACS- Anterior Cervical Standalone System
FDA 510(k)
FDA Class 2
·Orthopedic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804861·Baron Suction Tube, 5fr
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042533·Asian 4 Bicuspid Extraction
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180543283·ROD BENDER MODULAR TIP, 5.5mm
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055001·MTM® NO TRACE (TM) 018 UL/4-4
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055011·IN-OVATION® L 018 UPPER 6-6
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055101·IN-OVATION® L 018 UL/7-7
PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260
FDA 510(k)
FDA Class 2
·Radiology
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COULTER LH 780
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·October 6, 2008
FLOGARD
FDA Adverse Event
BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 26, 2013
REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·December 11, 2025
REVOLUTION CENTRIFUGAL BLOOD PUMP COATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·November 11, 2024
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code KFM·May 20, 2021
CENTRIFUGAL PUMP REVOLUTION 5
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·August 3, 2023
CENTRIFUGAL PUMP REVOLUTION 5
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·August 3, 2023
AVAN REINF RING SS 48/58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025