19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KAVO EVEREST TITANBLANK
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743670·ACHIMED ACHILLES SUPP SILVER IV
LEONE SPA
FDA UDI
LEONE SPA·08033707065869·EXTRAORAL ELASTICS 3/16" 14 oz
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690113973·PS-R Insert, Size 2 x 14mm
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0142140·Trial, TLIF, 32L OB CRV 7Deg, 14mm
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 2, 2020
ACCU-CHEK ® GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·January 18, 2024
SULZER DENTAL CERAMIC SYSTEM-SPLINE
FDA 510(k)
FDA Class 2
·Dental
MEDIAL ROTATION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·December 23, 2025
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 27, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·March 18, 2011
ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/T
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GDW·March 27, 2008
Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
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