13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
PnueAira (PNCU-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251086200·ceraMotion® Ti Shoulder transpa, 20 g / dental ...
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 28, 2024
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
ManoScan System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 14, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·September 8, 2011
SOLO IA TIP, STRAIGHT, .3MM
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQC·July 29, 2013
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 20, 2025
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024