10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HL168B
FDA 510(k)
FDA Class 2
·Cardiovascular
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BABY DOPPLEX 4002-TWINS, MODEL BD4002
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 7, 2019
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 13, 2013
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011
IMPLANTIUM
FDA Adverse Event
Other
·DENTIUM CO., LTD.·Product code DZE·February 22, 2008
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices in Healthcare Facilities.
FDA Enforcement
Class II
·Terminated·Steris Corporation·September 12, 2018
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