14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
FDA 510(k)
FDA Class 1
·General Hospital
TruForm
FDA UDI
Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134
ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS
FDA 510(k)
FDA Class 2
·Orthopedic
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS
FDA 510(k)
FDA Class 1
·General Hospital
SYRINGE 50ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 22, 2020
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
MAGIC WALLSTENT STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code MAF·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
ARCHITECT IPTH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code CEW·March 19, 2025
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
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