24 results · 22ms · Sources: EU EUDAMED, 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