12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
FDA 510(k)
FDA Class 2
·Cardiovascular
PF4 IGG
FDA Adverse Event
Malfunction
·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015
VITROS CHEMISTRY PRODUCTS VALP REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·April 27, 2011
OPTETRAK
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code FZX·April 8, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 10, 2008
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
ARROW PI PICC: 2:L 5FR X 55CM W/ 80CM HYDRO NI
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LJS·December 28, 2020
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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