11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Exactech, Inc.·10885862552396·TRIAL, TIBIAL SPACER, SIZE 3-4.5, 14mm
Giraffe OmniBed Carestation CS1
FDA 510(k)
FDA Class 2
·General Hospital
LUMINA 1600, 3300 AND 6600 SYSTEMS
FDA 510(k)
FDA Class 2
·Physical Medicine
FEMORAL NAIL, A/R 11/340 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KEIL·Product code JDS·December 4, 2008
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·September 9, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 29, 2013
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 28, 2020
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 28, 2020
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025