19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLACKSTONE PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
FDA 510(k)
FDA Class 2
·Microbiology
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
FDA 510(k)
FDA Class 2
·Dental
LINEAR 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 24, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026
TRUWAVE VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025
TRUWAVE VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 13, 2011
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·April 29, 2013
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·July 24, 2008
TRUWAVE, VAMP PLUS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·November 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
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024