33 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM
SAS BLOOD/SERUM/URINE/URINE HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023
GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 21, 2023
ME994 SONICATOR PLUS
FDA Adverse Event
Injury
·METTLER ELECTRONICS CORP.·Product code IMG·October 16, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 4, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 18, 2024
GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 13, 2024
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 19, 2023
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2025
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2024