20 results
·
24ms
·
Sources: EU EUDAMED, US FDA
X-RAY STAND & OPERATING CHAIR
FDA 510(k)
FDA Class 1
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113967·HYDRO-DISSECT CANNULA 25GA ANGLED 7MM
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450387467·
ELECSYS PTH CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STINGRAY ELECTROSURGICAL FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICRO VALVE, UNIT W/INTEGRAL RICKHAM RESERVOIR SYS
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·March 7, 2014
CODMAN HAKIM PROG VALVE W/ IN-LINE RESERVOIR & SG
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·March 7, 2014
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 8, 2025
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 5, 2024
ADVANIX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 8, 2025
ADVANIX BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 30, 2024
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 9, 2014
MACH1 GUIDE CATHETER
FDA Adverse Event
Malfunction
·AVAIL MEDICAL PRODUCTS INCORPORATED·Product code DQY·October 24, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 21, 2025
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 4, 2025
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018