27 results · 29ms · Sources: EU EUDAMED, US FDA

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INTROCAN SAFETY IV CATHETER

FDA 510(k)
FDA Class 2 ·General Hospital

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·August 11, 2025

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·October 2, 2025

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120207851·Carbide, cone flat, excavating and fissure bur

VYGON S A

FDA registration
VYGON S A·32 products·🇫🇷 France

SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X

FDA 510(k)
FDA Class 2 ·Orthopedic

KSEA DION-GRACIA SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

ZILVER BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

5.0 CM SHORT ATTACHMENT

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013

WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·March 16, 2011

Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020