10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REVOLIX DUO LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·February 26, 2019
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TETHER ACFS
FDA 510(k)
FDA Class 2
·Orthopedic
BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON, S.A.·Product code FMI·June 22, 2023
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 25, 2021
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·April 22, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 29, 2011
PROSTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code KNS·July 7, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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