15 results
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23ms
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Sources: EU EUDAMED, US FDA
REGAIN DESKTOP
FDA 510(k)
FDA Class 2
·Neurology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00531271·
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964021334·The ENDO CARRY-ON Procedure Kit contains all of...
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
FDA 510(k)
FDA Class 2
·Ophthalmic
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
FDA 510(k)
FDA Class 2
·Immunology
BD PHASEAL PROTECTOR (P55)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·December 10, 2020
BIO-CORKSCREW SUTURE ANCHOR
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·February 21, 2007
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 26, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·February 15, 2011
SYRINGE 5ML EMERALD BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 30, 2019
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
FDA Enforcement
Class II
·Ongoing·Acclarent, Inc.·December 29, 2021
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
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; 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