9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TORQMAX SHEATH GRIP ACCESSORY
FDA 510(k)
FDA Class 2
·Cardiovascular
HEMI-ARC SURGICAL NAVIGATOR
FDA 510(k)
FDA Class 2
·Neurology
EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT HE4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code OIU·February 6, 2026
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 5, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code JWH·May 3, 2011
145-DEG PE 36MM HUM LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·December 10, 2024
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