864 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
PENCAN SPINAL NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
SOL-M™ Hypodermic Needle
FDA UDI
Sol-Millennium Medical, Inc.·00818392015218·Sterile hypodermic needles intended to inject f...
Biosens cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110501655·box of 6 identical cartridges sealed in aluminu...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK112151·DD tempMED are pre-colored dental milling blank...
T-Crystal cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110500252·Box of 6 identical cartridges sealed in aluminu...
Disc Prep
FDA UDI
Life Spine, Inc.·00190837089993·
T-Crystal cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110506155·5 identical cartridges sealed in a vacuum bag ;...
BIFURCATED VACCINATING NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
NP15
FDA 510(k)
FDA Class 2
·Anesthesiology
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873105892·3.5mm Locking Medial Distal Tibial Plate, 6 Hol...
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 14, 2013
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER VAMP COMBO
FDA Adverse Event
Malfunction
·Product code DRS·August 8, 2008
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 25, 2011
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·August 9, 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
VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 17, 2018
VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2018