18 results · 22ms · Sources: EU EUDAMED, US FDA

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MegaGen Dental Implant Systems Portfolio - MR Conditional

FDA 510(k)
FDA Class 2 ·Dental

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA UDI
FX SOLUTIONS·03701037318119·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY ...

SFI-ANCHOR

FDA 510(k)
FDA Class 2 ·Dental

WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA 510(k)
FDA Class 2 ·Anesthesiology

ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code BSP·November 21, 2019

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

APEX PIN ADAPTOR - SHORT HOFFMANN LRF FOR PIN Ø3-4-5-6MM

FDA Adverse Event
Injury ·STRYKER TRAUMA SELZACH·Product code KTT·November 6, 2014

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·August 11, 2011

PK DISSECTING FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 16, 2013

ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·July 5, 2023

The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

FDA Enforcement
Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

CODMAN Disposable Perforator, 14mm. Cranial perforator.

FDA Enforcement
Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020