11 results · 29ms · Sources: EU EUDAMED, US FDA

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VERIFY CHALLENGE PACKS - VERSION 2

FDA 510(k)
FDA Class 2 ·General Hospital

MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AVANTE CURELIGHT

FDA 510(k)
FDA Class 2 ·Dental

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

FREESTYLE AORTIC ROOT BIOPROSTHESIS

FDA Adverse Event
Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 23, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 13, 2011

SYMPHONY

FDA Adverse Event
Malfunction ·ELA MEDICAL·Product code DXY·July 10, 2008

COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER

FDA Adverse Event
Malfunction ·ROCHE DIAGNSOTICS, LTD.·Product code JJF·October 4, 2010

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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