65 results · 37ms · Sources: EU EUDAMED, US FDA

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PDS(TM) BARBED SUTURES

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

Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.

FDA Enforcement
Class II ·Terminated·Ethicon, Inc.·December 18, 2013

SERENGETI® MI Retractor System

FDA UDI
VB Spine LLC·10888857583283·Gelpi Retractor 70 mm, L

Link OptiStem

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575283064·Modular stem, uncemented, Ti6Al4V, oval

SNORE GUARD

FDA 510(k)
FDA Class 2 ·Dental

COCAINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Widex

FDA UDI
Widex A/S·05706069645927·COMPASS GPS V2.2 package (Spanish)

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ARCHITECT HAVAB-IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·May 8, 2026

ARCHITECT HAVAB-IGG

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·April 3, 2026

ACCU-CHEK ® MOBILE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 15, 2013

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·May 25, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

LOCKING CAP

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KTT·October 19, 2012

LOCKING CAP

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KTT·October 19, 2012

LOCKING CAP

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KTT·October 19, 2012

LOCKING CAP

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KTT·October 19, 2012

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020

GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022