9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036026936·
MODIFICATION TO CAVERMAP SURGICAL AID
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SOFTLINE SPRING CLIP
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 16, 2025
3.2MM X 460MM COCR THD TIP
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HTY·May 2, 2013
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·August 18, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·May 5, 2011
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024