14 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ERA-20
FDA 510(k)
FDA Class 2
·Cardiovascular
VASOVIEW HemoPro Endoscopic Vessel Harvesting System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
ADULT 7.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK HEALTH CARE·Product code BTR·June 6, 2014
SLDM, DIGITAL TOWER
FDA Adverse Event
Malfunction
·ICAD INC.·Product code LMA·June 26, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 18, 2015
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·February 25, 2026
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·February 25, 2026
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·February 25, 2026
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·February 25, 2026
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·February 25, 2026
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·February 25, 2026
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·February 25, 2026
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022