24 results · 24ms · Sources: EU EUDAMED, US FDA

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HIVOX ELECTRIC STIMULATOR OTC TENS

FDA 510(k)
FDA Class 2 ·Neurology

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015374483·STANDARD LOCKING SCREW L65.0MM D4.0MM

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015373981·STANDARD LOCKING SCREW L65.0MM D4.0MM STERILE

BONAMATES SERIES

FDA 510(k)
FDA Class 2 ·Dental

ZYSTON ARC INTERBODY SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

LOCKING SCREW, FULLY THREADED 5X55 MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 30, 2010

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 31, 2013

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 17, 2011

PINNACLE PELVIC FLOOR REPAIR KIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FTM·August 28, 2008

REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·December 11, 2025

UNKNOWN LUMBAR IMPLANT

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022

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

PKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

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

ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

CENTRIFUGAL PUMP REVOLUTION 5

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·August 3, 2023