9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BIODEGRADABLE SURGICAL STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756375849·OPEN KNEE PACK
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00812171023739·TI INTERFERENCE SCISSORSEW, 7.0MMx23MM, STER
Nitrile Patient Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 22, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024