12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ENDOSTAPLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bioseal Inc.
FDA UDI
BIOSEAL·00630094118291·Poly Drape 29.5" x 29.5"
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327662016·2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327662023·2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327661989·2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
BEHRING CHROMOTIMER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Microlife Non-Contact Infrared Forehead Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
SECURA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·December 1, 2010
THINLINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
GIA STAPLER 3.5MM
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GAG·July 1, 2014
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025