11 results
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25ms
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Sources: EU EUDAMED, US FDA
BUN REAGENT ASTRA 4 & 8 ANALYZERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bardia® Coude Olive Tip Urethral Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741039065·Bardia® Coude Olive Tip Urethral Catheter
LEONE SPA
FDA UDI
LEONE SPA·08033707008170·STRAIGHT WIRES SPRING HARD 18x25
BARDIA® COUDE OLIVE TIP URETHRAL CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code KOD·November 13, 2025
Promaxo MRI System
FDA 510(k)
FDA Class 2
·Radiology
DUAL NEEDLE SUTURE PASSER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code KOD·May 5, 2026
REGENCY SR+
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·May 9, 2014
VISUM LED II SURGICAL LIGHT
FDA Adverse Event
Malfunction
·STRYKER COMMUNICATIONS·Product code FSY·October 19, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·May 26, 2015
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