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