19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LED light therapy mask (FM-01, FM-02, FM-03)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLOBAL CAP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105435·GLOBAL C.A.P. CTA CUTTING BLOCK SIZE 44
GLOBAL CAP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105411·GLOBAL C.A.P. CTA CTA HEAD TRIAL 44 X 15
GLOBAL CAP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105428·GLOBAL C.A.P. CTA CTA HEAD TRIAL 44 x 18
GENZYME CONTRAST II HCG URINE/SERUM TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK SPHERE CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
COMPRESSOR MINI
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code BTI·July 29, 2011
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 12, 2013
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026