10 results
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29ms
·
Sources: EU EUDAMED, US FDA
DAWN DISPOSABLE BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088088·Box Cutter, 9mm x 7mm
IMPAX VOLUME VIEWING 3.0
FDA 510(k)
FDA Class 2
·Radiology
STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TENDRIL DX
FDA Adverse Event
ST. JUDE MEDICAL·Product code DTB·January 10, 2013
MEDFUSION 3010A SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD·Product code FRN·December 13, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
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