28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
FDA 510(k)
FDA Class 2
·Cardiovascular
RIGIDFIX
FDA UDI
Medos International Sàrl·10886705020119·RIGIDFIX CURVE Femoral Rod Soft Tissue Only 8.5...
18M - Burn Relief
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030319·18M - Burn Relief
GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BWF-5 MEDICAL LASER SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOST OPTIONS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MOTO PARTIAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·November 4, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2023
MOTO PFJ SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 1, 2025
MOTO PARTIAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·April 23, 2026
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
M2A 38MM MOD HD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 30, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 31, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2025
MAGNETOM Cima.X (DE). Model Number: 11647158.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MOTO PFJ SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·May 28, 2026
MOTO PARTIAL KNEE SYSTEM - MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·April 14, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2025
MOTO PARTIAL KNEE SYSTEM - MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·April 30, 2026