18 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.

Orthodontic Appliance

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE

FDA 510(k)
FDA Class 2 ·General Hospital

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·June 6, 2013

FREEZOR MAX CARDIAC CRYOABLATION CATHETER

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code LPB·July 27, 2011

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 30, 2008

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·March 17, 2022

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Injury ·COOK INC·Product code MMX·September 29, 2021

SEE H10 NARRATIVE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·June 3, 2022

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·August 15, 2022

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·January 30, 2023

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Injury ·COOK INC·Product code MMX·February 6, 2023

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·July 27, 2021

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·November 4, 2022

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·March 28, 2022

ALINITY C MAGNESIUM

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JGJ·February 16, 2026

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Injury ·COOK INC·Product code MMX·August 18, 2022