14 results · 34ms · Sources: EU EUDAMED, US FDA

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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