15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
FDA 510(k)
FDA Class 2
·Dental
Bolt Cutters
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068844·
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873106226·3.5mm Locking Distal Fibula Plate, 4 Holes, Right
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
FDA 510(k)
FDA Class 2
·Hematology
ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·August 2, 2018
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 7, 2022
OT VERIOVUE METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2017
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·July 11, 2016
WST 6:1 F. VDW.GOLD/SILVER
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EGS·June 15, 2022
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 6, 2008
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; 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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025