19 results
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21ms
·
Sources: EU EUDAMED, US FDA
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
FDA 510(k)
FDA Class 2
·Physical Medicine
AtoN Classic Headlight with 7' Fiber Optic Cable
FDA UDI
LONG ISLAND TECH·00851610007183·Light, Surgical, Endoscopic, Accessory
ALLROUND 55 LF
FDA 510(k)
FDA Class 2
·Dental
SPINA SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 28, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 21, 2008
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·December 20, 2024
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code DEW·August 6, 2019
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·August 30, 2019
BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024