10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PEDI-SPIDER STRAP
FDA 510(k)
FDA Class 1
·General Hospital
AF531
FDA UDI
Respironics, Inc.·00606959007451·AF531 Mask with Standard Elbow, with 4 Point He...
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·September 4, 2014
CLASSIC ADULT COILED PD CATHETER
FDA Adverse Event
Malfunction
·MEDIGROUP, INC·Product code FJS·April 13, 2011
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001631;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015