19 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
INTREPED, Intraosseous Fusion Device
FDA UDI
Auxano Medical LLC·00850055649378·INTREPED 08 Tap (Beta)
ZAVATION F3D-Z CIF
FDA UDI
Zavation LLC·00197157020941·F3D-Z CIF 16mmx18mmx8mm - 6deg
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197056229·Gray Gall Duct Clamp
1x2 te...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197056212·Gray Gall Duct Clamp
1x2 te...
ENDOSCOPIC APPLICATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SEVOFLURANE VAPORIZER ADAPTOR
FDA 510(k)
FDA Class 2
·Anesthesiology
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 29, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2025
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·December 22, 2022
BD POSIFLUSH¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·October 10, 2022
IDENTITY ADX XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
EXPEDIUM 4.35MM DOUBLE-LEAD TAP
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code LXH·May 31, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 16, 2011
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 20, 2022
13 CM TRICUT BLADE
FDA Adverse Event
Malfunction
·MEDTRONIC ENT (JACKSONVILLE)·Product code HAW·July 23, 2015
CURVED SINUS BURS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EQJ·June 2, 2014
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.
FDA Enforcement
Class I
·Terminated·Teleflex Medical·July 1, 2015
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026