21 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
StaXx® XD System
FDA UDI
Spine Wave, Inc.·10840642100600·Cartridge Convex Expandable Implant 26x9x7mm
NMI IC
FDA 510(k)
FDA Class 2
·General Hospital
OSRAM ITOS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NON21430CNS
FDA Adverse Event
MEDLINE INDUSTRIES INC·Product code GDY·April 29, 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
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018
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
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·July 9, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025