11 results
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21ms
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Sources: EU EUDAMED, US FDA
ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Arthrex®
FDA UDI
ARTHREX, INC.·00888867533240·Switching Stick, 6.3 x 245mm
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
FDA 510(k)
FDA Class 2
·General Hospital
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
FDA 510(k)
FDA Class 2
·Ophthalmic
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
14F X 32CM SPLIT CATH III
FDA Adverse Event
Malfunction
·MEDCOMP·Product code MSD·April 11, 2013
SILICONE ADVANCED OPTIC LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·June 19, 2008
CELL-DYN 1800 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·April 19, 2011
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
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