11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INQU
FDA 510(k)
FDA Class 2
·Orthopedic
OPTIMUM WETTING AND REWETTING DROP
FDA 510(k)
FDA Class 2
·Ophthalmic
TRICERAM
FDA 510(k)
FDA Class 2
·Dental
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 19, 2025
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 22, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
GENESIS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code HSA·July 8, 2008
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
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