14 results · 20ms · Sources: EU EUDAMED, 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