15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TAMCENAN OCULAR EXPLANTS AND BANDS
FDA 510(k)
FDA Class 2
·Ophthalmic
DELTRAN
FDA UDI
UTAH MEDICAL PRODUCTS, INC.·H6719023080·DELTRAN II - ABC SYSTEM, Disposable Pressure Tr...
POLESTAR, MODEL N-30
FDA 510(k)
FDA Class 2
·Radiology
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 21, 2016
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 24, 2015
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 23, 2015
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 9, 2013
HYALURONIC ACID, HYALURONIC ACID
FDA Adverse Event
Injury
·Product code LMH·June 25, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 8, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·November 11, 2010
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 17, 2013
TI STERNAL LOCKING STAR PLATE- 12 HOLES
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·September 14, 2018
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012