21 results · 22ms · Sources: EU EUDAMED, 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