11 results
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26ms
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Sources: EU EUDAMED, US FDA
ASO-CUBE(TM)
FDA 510(k)
FDA Class 1
·Microbiology
OnBrace Crown LL3 w/ AWT (5/pk)
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199013710·
PUR NP Implant 6.0 x 12mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549107535·The PUR is a self-tapping, double thread screw ...
CARDEON ASCENDING BALLOON CANNULA (ABC)
FDA 510(k)
FDA Class 2
·Cardiovascular
ON CALL PLUS DIABETES MONITORING SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 19, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·December 14, 2012
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 17, 2010
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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