141 results · 28ms · Sources: EU EUDAMED, US FDA

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SEAL ONE

FDA 510(k)
FDA Class 2 ·Cardiovascular

n.a.

FDA UDI
Karl Storz GmbH & Co. KG·04048551054161·FARRIOR Ear Speculum, Ø 8 mm

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")

SMARTPILOT VIEW MODEL MK04500

FDA 510(k)
FDA Class 2 ·Anesthesiology

SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER

FDA 510(k)
FDA Class 2 ·Dental

ALARIS PUMP MODULE

FDA Adverse Event
Injury ·CAREFUSION CORPORATON·Product code FRN·June 8, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 21, 2013

ARCHITECT HBSAG QUALITATIVE II

FDA Adverse Event
Malfunction ·ABBOTT IRELAND·Product code KSJ·September 26, 2014

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code FGE·December 13, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 24, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 17, 2023

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code GBO·October 11, 2021

ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 1, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 5, 2024

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·August 6, 2020

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code GBO·August 11, 2020

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code GBO·August 11, 2020

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·November 30, 2020

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 14, 2020