15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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