9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALEO VBR
FDA 510(k)
FDA Class 2
·Orthopedic
COALESCENT U-CLIP- AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·October 20, 2025
*
FDA Adverse Event
ETHICON ENDO-SURGERY, INC.·Product code GDW·April 17, 2013
PIC 50
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC·Product code MKJ·March 25, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
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