11 results
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35ms
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Sources: EU EUDAMED, US FDA
CG-7000DX-BT ECG RECORDER/TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
PerforMax
FDA UDI
Respironics, Inc.·00606959011892·Performax Mask with Entrainment Elbow, Leak 2, ...
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106372·HELVESTON FIXATION FORCEPS WITH LOCK
ACUMATCH GXL 15DEG LINER 36MM SZ J
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·April 19, 2024
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
FDA 510(k)
FDA Class 1
·Ophthalmic
REPROCESSED GUIDEWIRES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·January 11, 2013
FLEXTEND
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 11, 2013
DEPUY 1 GENTAMICIN CEMENT 40G
FDA Adverse Event
Injury
·DEPUY CMW·Product code MBB·April 11, 2011
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DSP·May 22, 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