9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
YOURS TRULY ASYMMETRICAL BREAST FORM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471144330·PASSING PIN - DRILL TIP 2.4mm DIA x 385mm
CRANIAL REMOLDING ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
FDA 510(k)
FDA Class 2
·General Hospital
BD PLASTIPAK 20 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 25, 2020
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 11, 2013
CE INTERMATE SV 200, 48 PACK,50125
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 30, 2010
MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·July 2, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015