25 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flowable Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486020132·MCK BASEPLATE TEMPLATE (SIZE 6 RM/LL)
Monza Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711601361·36mm Cervical Plate, 1 Level
SMOOTH K-WIRE, BAYONET POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016226·
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962154472·JANSEN BAYONET BIPOLAR FORCEPS, 6 1/2"
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 4, 2026
PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR
FDA 510(k)
FDA Class 2
·Radiology
RESPICHAMBER VALVED HOLDING CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 5, 2024
16MM CANN PERCUTANEOUS HOLLOW DRILL BIT
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·October 27, 2020
Widex
FDA UDI
Widex A/S·05706069895995·WIDEX EVOKE E-FA (Deep Blue ) 50, Telecoil, Vol...
Widex
FDA UDI
Widex A/S·05706069870718·WIDEX EVOKE E-FM (Deep Blue ) 50, RC coil
Widex
FDA UDI
Widex A/S·05706069897654·WIDEX EVOKE E-FP (Deep Blue ) 50, Telecoil, Vol...
Widex
FDA UDI
Widex A/S·05706069923810·WIDEX MOMENT MBB3D 50 (Deep blue)
VIVA XT
FDA Adverse Event
Injury
·MEDTREONIC S.A. (SMO)·Product code NIK·October 10, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
BD SYRINGE¿ WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·May 29, 2018
BD SYRINGE¿ WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 12, 2018
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015