13 results
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20ms
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Sources: EU EUDAMED, US FDA
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sklar®
FDA UDI
SKLAR CORPORATION·10649111179983·YANKAUER SUCTION TUBE
Rongeur
FDA UDI
KATENA PRODUCTS, INC.·00841668108482·KERRISON RONGEUR SIZE 1
Australis ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127886·
FUTURA TOPCAP NON GAMMA-2
FDA 510(k)
FDA Class 2
·Dental
STEATHSTATION TREATMENT GUIDANCE PLATFORM
FDA 510(k)
FDA Class 2
·Neurology
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·April 22, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·April 21, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 8, 2008
IPC® FOOTPEDAL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·October 29, 2024
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·February 11, 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