14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AccelFix Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003739·Steerable Diagnostic EP Catheter , LARGE 4.0, 8...
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003746·Steerable Diagnostic EP Catheter , LARGE 4.0, 8...
MODIFICATION TO MARSPO2, MODEL 2001
FDA 510(k)
FDA Class 2
·Cardiovascular
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UNK
FDA Adverse Event
Injury
·NEUROMODULATION·Product code EZW·November 5, 2007
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 29, 2011
COULTER® LH 750 HEMATOLOGY ANALYXZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 2, 2013
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code NLH·April 10, 2026
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2019
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021