15 results · 21ms · Sources: EU EUDAMED, US FDA

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V8 Transluminal BAV Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699557·GENUMEDI PSS BLUE SIZE III

N/A

FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138188334·SERPENTINE COLLAR 4IN X 13IN-17IN

AGXO

FDA UDI
Oticon A/S·05707131287472·H110V2, MINIRITE 312 WL CNB AGXO

PAP-CAP

FDA 510(k)
FDA Class 2 ·Anesthesiology

REPROCESSED HARMONIC SCALPELS

FDA 510(k)
FDA Unclassified ·Unknown

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 9, 2018

TOTALCARE BARIATRIC PLUS BED

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·May 30, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

ALLURA XPER FD20

FDA Adverse Event
Other ·PHILIPS MEDICAL SYSTEMS·Product code IZI·August 21, 2008

HISTOACRYL FLEXIBLE PACK 5

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

FDA Adverse Event
Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

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

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024