12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
FDA 510(k)
FDA Class 2
·Hematology
Amara View
FDA UDI
Respironics, Inc.·00606959009394·Labeling - mask sizing gauge
TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC
FDA 510(k)
FDA Class 2
·Dental
SP Ø 4.1MM RN, SLACTIVE® 8MM, TIZR, NTP
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·August 18, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·December 25, 2019
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·December 25, 2019
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 15, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011