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

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CXI TRIFORCE

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·August 1, 2015

NA

FDA UDI
Smith & Nephew, Inc.·03596010584748·KEY PERIOSTEAL ELEVATOR 19.0 BL ...

LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,

FDA 510(k)
FDA Class 2 ·Orthopedic

VITAL SERUM CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 14, 2013

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 18, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025

INTROCAN SAFETY® 3

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

INTROCAN SAFETY® 3

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025

INTROCAN SAFETY® 3

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

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018