16 results · 23ms · Sources: EU EUDAMED, US FDA

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STASILON FR

FDA 510(k)
FDA Unclassified ·Unknown

MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

FDA 510(k)
FDA Class 2 ·Dental

INTRALASE 600C LASER KERATOME

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

TRIAGE D-DIMER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·May 11, 2018

TRIAGE PROFILER SOB PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019

TRIAGE PROFILER SOB PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019

TRIAGE D-DIMER TEST

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·October 2, 2019

TRIAGE D-DIMER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·September 17, 2019

TRIAGE D-DIMER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·May 7, 2019

TRIAGE D-DIMER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·August 17, 2018

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 23, 2013

HILL-ROM 100 LOW BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 31, 2011

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

FDA Enforcement
Class II ·Terminated·Exactech, Inc.·October 7, 2020

XP-XP Tibial Tray - Interlok 69 mm Item # 195754

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

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