13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Deep Conical (DC) Implants and Accessories
FDA 510(k)
FDA Class 2
·Dental
Aquila Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125868·
Pinehurst Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030803·
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTHREX TIBIAL GRAFTBOLT
FDA 510(k)
FDA Class 2
·Orthopedic
STARKEY
FDA UDI
Starkey Laboratories, Inc.·00842318176868·
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·June 10, 2025
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 8, 2025
GMK-SPHERE TIBIAL INSERT FIXED FLEX #6/10 MM LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 27, 2017
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 11, 2013
INFUSO.R.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
CADD-PRIZM VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)·Product code FRN·September 15, 2008
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019