166 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Promisemed Triple Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112670·BARRON CORNEAL PUNCH 9.0MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113400·IMPLANT KNIFE 4.0MM (BX/5)
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
FDA 510(k)
FDA Class 2
·Cardiovascular
RANDOX C-REACTIVE PROTEIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025
SITTER SELECT
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·February 13, 2009
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
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·July 2, 2013
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
HF UNIT "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·November 19, 2023
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
ELECTROSURGICAL GENERATOR "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·July 8, 2022
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