39 results · 27ms · Sources: EU EUDAMED, 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