18 results · 22ms · Sources: EU EUDAMED, US FDA

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Disposable Medical Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NA

FDA UDI
Synthes GmbH·10886982153715·4.5MM CORTEX SCREW 85MM

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551114246·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1211-1...

Deltec

FDA UDI
ICU MEDICAL, INC.·10610586023620·

PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HealthCCSng

FDA 510(k)
FDA Class 2 ·Radiology

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026

ALARIS PUMP MODULE ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORPORATION, SAN DIEGO·Product code FPA·August 6, 2014

SYNVISC (HYLAN G-F 20) INJECTION

FDA Adverse Event
Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·July 21, 2011

TALENT TAA

FDA Adverse Event
Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 9, 2013

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4085-24

FDA Recall
Terminated ·Deltec, Inc·Product code LJT·March 29, 2004

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 2026

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019