17 results
·
34ms
·
Sources: EU EUDAMED, US FDA
CoStorSol plus G
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106143·HOSKIN #28 FORCEPS STRAIGHT
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575298068·Knee femur prosthesis trial - General Instrument
MaxFuse,VBR, 12 (D) x 14 (W) x 20 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468056025·12 (D) x 14 (W) x 20 (H)
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575297122·Knee femur prosthesis trial - General Instrument
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575297474·Knee femur prosthesis trial - General Instrument
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575298273·Knee femur prosthesis trial - General Instrument
MODIFICATION TO SHOULDER FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014