55 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sidestream
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730004402·Sidestream Plus Patient Pack Retail
SafeGuide®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021156·Esophageal Dilator, 51 French
MaxFuse VBR, 10 (D) x 12 (W) x 58 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055714·10 (D) x 12 (W) x 58 (H)
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973837·
DURACON CS TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064856·Corpectomy, 12Dx14Wx51H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929045121·Corpectomy, 12Dx14Wx51H 6°
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·April 13, 2012
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·May 21, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 29, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 7, 2011
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·July 30, 2012
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·July 30, 2012
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 6, 2012
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·June 23, 2012
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·August 25, 2012