14 results
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22ms
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Sources: EU EUDAMED, US FDA
ZYOPTIX XP EPI SEPARATOR SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0624650·6mm H x 24mm W x 65mm L x 0 degrees XLIF
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X062465120·6mm H x 24mm W x 65mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L062465120·6mm H x 24mm W x 65mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X06246580·6mm H x 24mm W x 65mm L x 8 degrees XLIF
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
FDA 510(k)
FDA Class 2
·Anesthesiology
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
STONEBREAKER SINGLE USE PROBE
FDA Adverse Event
Malfunction
·COOK INC·Product code FFK·March 28, 2018
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·March 18, 2011
SURGICEL ABSORBABLE HEMOSTAT
FDA Adverse Event
Injury
·ETHICON, INC.·Product code LMF·June 17, 2008
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