11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Barrigel Injectable Gel
FDA 510(k)
FDA Class 2
·Radiology
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807032206411·OVATION® SS ACU 20X20 LW SM
CURLIN INFUSION 6000CMS IOD IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·August 23, 2011
GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
FDA 510(k)
FDA Class 2
·Anesthesiology
7800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008
HOLMES
FDA Adverse Event
Malfunction
·SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS·Product code KFZ·June 25, 2013
THRUWAY GUIDE WIRES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·August 23, 2011
SENSOR MMT-7040D1 GUARDIAN4 1PK OUS 1
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·July 29, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021