19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPATCH ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Premier Cavity Prep
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783008302·BLACK CUTTING INSTR 63/64
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00312291·
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003031·Jacobson Micro Needle Holder Flat Handle
WACKERS-LIU CQ SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CHRONOS STRIP 100*25*3
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code MQV·October 4, 2012
BIO-CORKSCREW SUTURE ANCHOR
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·February 21, 2007
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·February 28, 2011
TRANSTAR CATH LAB SET W/1050 4-GANG MANIFOLD
FDA Adverse Event
Malfunction
·SMITHS MEDICAL, ASD.·Product code DRS·February 21, 2008
VARISOFT
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 2024
VARISOFT
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 2024
VARISOFT
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
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