10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VINTAGE ART
FDA 510(k)
FDA Class 2
·Dental
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO
FDA 510(k)
FDA Class 1
·Dental
S5 CONSOLE FOR 4 PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 1, 2010
LOGIC TIBIA PS MOD INSRT SZ 5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 20, 2024
BD¿ RELION® INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 13, 2018
CADD -SOLIS AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD·Product code MEA·April 12, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 6, 2011
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·ALARIS MEDICAL SYSTEMS, INC.·Product code FRN·July 9, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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