9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES ZERO-P
FDA 510(k)
FDA Class 2
·Orthopedic
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
ALI 3D TOOL MODULE FOR MEDICAL IMAGES
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·April 30, 2013
CAPD DISCONNECT Y SET
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 16, 2014
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 18, 2011
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LZO·April 24, 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