10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Abutment Base 4.5mm (B)
FDA UDI
STERNGOLD DENTAL LLC·00841549114212·Intended for use with dental implants to suppor...
CODERE-DURETTE ORBITAL FLOOR IMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
HA-TI (HAND-TITANIUM SCREW) IMPLANT
FDA 510(k)
FDA Class 2
·Dental
STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2020
BD BACTEC PEDS PLUS/ F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·July 14, 2021
ALARIS PCA MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FRN·June 4, 2014
ARTHROSCOPE
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code HRX·January 9, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 22, 2010
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