21 results
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21ms
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Sources: EU EUDAMED, US FDA
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
FDA 510(k)
FDA Class 2
·Microbiology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0624400·6mm H x 24mm W x 40mm L x 0 degrees XLIF
OsteoMed
FDA UDI
OSTEOMED LLC·00845694008556·2.4mm x 40mm Lag Screw
Yellowstoe
FDA UDI
SUMMIT SPINE LLC·B587X062440120·6mm H x 24mm W x 40mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X06244080·6mm H x 24mm W x 40mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L062440120·6mm H x 24mm W x 40mm L XLIF Trial 12 degree Lo...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694089807·2.4 x 40mm Lag Screw, Sterile
F-11 FOLDING POWER CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO CLEARFIL LINER BOND 2V
FDA 510(k)
FDA Class 2
·Dental
G7 NEUTRAL E1 LINER 32MM B
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·November 27, 2018
G7 NEUTRAL E1 LINER 32MM B
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·November 27, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
WECK HEM-O-LOK ENDO APPLIER, ML
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·March 18, 2011
ULTRA 2 MONORAIL CUTTING BALLOON
FDA Adverse Event
Death
·BSC LETTERKENNY·Product code LOX·June 18, 2008
MEDTRONIC HALL PROSTHETIC HEART VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWQ·December 17, 2021
MEDTRONIC HALL PROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWQ·December 17, 2021
MEDTRONIC HALL PROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWQ·December 17, 2021
UNKNOWN IMPACTOR
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWA·October 25, 2021
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015