14 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PARAGON INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001342·Cervical Collar
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743649·ACHIMED ACHILLES SUPP SILVER I
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717102458·Midway Select Imp Mat'l Reg/Mono Reg Set
UD-1000 ULTRASONIC A/B SCANNER
FDA 510(k)
FDA Class 2
·Radiology
SPECTRUM SILICONE FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD INSYTE¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 23, 2018
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·March 25, 2013
ORAL / ENTERAL SYRINGE
FDA Adverse Event
Other
·PHILIPS RESPIRONICS, INC.·Product code KYZ·March 11, 2011
VITROS ECI IMMUNODIAGNOSTICS SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·March 26, 2008
COMP PRIMARY STEM 8MM MINI
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·July 9, 2021
UNKNOWN HUMERAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·July 9, 2021
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 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