12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDICAL PROCEDURE TRAY
FDA 510(k)VuePoint
FDA UDI
Nuvasive, Inc.·00887517175625·VuePoint Screw, 4x10mm Fav Angle Tulip
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
MATRYX INTERFERENCE SCREW (5.0-6.5MM)
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 24, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·WALDEMAR LINK, GMBH & CO·Product code NTG·November 12, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·September 17, 2025
BIOLOX DELTA CER FEM HD 28/0MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·August 18, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 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