19 results · 21ms · Sources: EU EUDAMED, US FDA

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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