11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BIO PACK MODEL 200
FDA 510(k)
FDA Class 2
·Cardiovascular
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209115884·
BINAXNOW INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
da Vinci Xi Hasson Cone
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOLOC(TM) STAR 10 DRIVER
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRS·March 15, 2012
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECH CTR·Product code HQC·April 2, 2014
MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·July 10, 2012
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 22, 2010
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015