14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
SURGICAL RULER AND PEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690194989·AK3 Size 6 PS Trials Pan
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690195023·AK3 Size 6 PS Trials Pan Insert
ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
McLean-Ring Enteral Feeding Tube Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENERGEN
FDA Adverse Event
Death
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·May 5, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 6, 2010
MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET
FDA Adverse Event
Injury
·COOK INC·Product code KNT·November 10, 2021
IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø7,5X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
IM REAMER, AO FITTING BIXCUT Ø8,5X480 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 2, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024