39 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ArgenZ HT+ 98x10 B1
FDA UDI
ARGEN CORPORATION, THE·D818121977·Dental porcelain/ceramic restoration kit
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
TAPERED SCREW-VENT T IMPLANT
FDA 510(k)
FDA Class 2
·Dental
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 22, 2026
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 28, 2024
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 22, 2026
IMP,TSV,6.0,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 15, 2025
IMP,TSV,3.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 12, 2024
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 10, 2024
HALO90 ABLATION CATHETER
FDA Adverse Event
Other
·BARRX MEDICAL INC.·Product code GEI·June 3, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 21, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 13, 2008
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 6, 2024
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 8, 2024
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 4, 2023
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025