16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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