17 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mobility+ Enteral Feeding System OTC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOGIQ F SERIES
FDA 510(k)
FDA Class 2
·Radiology
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 30, 2020
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 30, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
TRANSPORT SERIES
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 25, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Corp. Hq.)·October 2, 2024
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 30, 2015
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 30, 2015
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 30, 2015
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·August 18, 2015
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·April 13, 2023
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025