22 results · 24ms · 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.

HRH-63-8 HEAD ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

FRYE & CO

FDA UDI
FGX INTERNATIONAL INC.·00193033483077·

CORDIS SLALOM PTA BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

ARCHITECT B12

FDA Adverse Event
Malfunction ·ABBOTT IRELAND·Product code CDD·November 20, 2013

PRECISION SPECTRA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 17, 2024

ARCHITECT B12

FDA Adverse Event
Malfunction ·A.I.D.D LONGFORD·Product code CDD·December 10, 2013

UNKNOWN BIOMET DVR-A PLATE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·August 15, 2017

UNKNOWN BIOMET DVR-A PLATE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code LXT·August 15, 2017

UNKNOWN BIOMET DVR-A PLATE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·August 15, 2017

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 20, 2013

ASR XL TAP SLV ADAP 12/14+5

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code LWR·March 14, 2008

UNKNOWN BIOMET DVR-A PLATE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·August 15, 2017

UNKNOWN BIOMET DVR-A SCREWS

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code LXT·August 16, 2017

UNKNOWN BIOMET DVR-A PLATE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·August 15, 2017

UNKNOWN BIOMET DVR-A PLATE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·August 15, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·February 27, 2023

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025