21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PANAMA Anterior Cervical Plate (ACP) System
FDA 510(k)
FDA Class 2
·Orthopedic
TWINFIX/DURABRAID
FDA UDI
Smith & Nephew, Inc.·03596010485663·TWINFIX TI 3.5 SUTURE ANCHOR W/TWO 38
36M - Black & Veach - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK
CANNABINOIDS URINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VCF PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·November 3, 2014
MEDLINE UNITE
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025
PLUS SL
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·October 23, 2008
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 8, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NGV·April 19, 2018
5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code KTT·May 18, 2015
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·March 23, 2018
DigitalDiagnost C50 1.1
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·September 7, 2022
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025