17 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNIMED TEMPERATURE PROBE
FDA 510(k)
FDA Class 2
·General Hospital
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508215·
SafeGuide®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021071·Esophageal Dilator, 27 French
MaxFuse VBR, 10 (D) x 12 (W) x 46 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055479·
AUDIT MICROCV HS-CRP LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLEARFIL SA PRIMER
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929059517·Convexx Corpectomy, 12Dx14Wx27H, 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034637·Corpectomy, 12Dx14Wx27H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929043103·Corpectomy, 12Dx14Wx27H 0°
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·June 7, 2011
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·July 18, 2013
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021
KIT BD MAX ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025