18 results · 36ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Dynarex Eye Cups

FDA 510(k)
FDA Unclassified ·Unknown

BONE SCREW, CORTICAL

FDA UDI
Biomet Orthopedics, LLC·00887868004773·

ProLift Trial

FDA UDI
Life Spine, Inc.·00190837088996·

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE

HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX

FDA 510(k)
FDA Unclassified ·Unknown

APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010

FDA 510(k)
FDA Class 2 ·Orthopedic

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 29, 2024

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 5, 2019

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·September 6, 2019

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 5, 2019

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 28, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 7, 2025

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016