19 results · 24ms · Sources: EU EUDAMED, US FDA

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CRP Vario

FDA 510(k)
FDA Class 2 ·Immunology

ECHO BI-METRIC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304463387·

Echo® Bi-Metric® Hip System

FDA UDI
Biomet Orthopedics, LLC·00887868260643·

Sonic

FDA UDI
Sonic Innovations, Inc.·05711583032689·ET40, KIT 13 NFM R BE ENCHANT 40

Aspida

FDA UDI
ALPHATEC SPINE, INC.·00840967190969·LUMBAR DTS GUIDE 18MM

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198475·AK3 Ultra Insert Trial Size 1, 18mm

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419105·Integra® Miltex® House Forceps, 3-1/4" Shaft, 0...

SteriLance Impress Pro safety lancet 21G 1.8mm

FDA UDI
Sterilance Medical (Suzhou) Inc.·16945630123358·

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107958·TRIAL 90-SRK-192118 POLY-MPCS 1X18 LEFT

ANGIOGRAPHIC CATHETER, MODEL ANGIOS

FDA 510(k)
FDA Class 2 ·Cardiovascular

SNORE GUARD ADVANCE

FDA 510(k)
FDA Class 2 ·Dental

U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

FDA Adverse Event
Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022

U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB

FDA Adverse Event
Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022

U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

FDA Adverse Event
Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023

PULSE GEN MODEL 102

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·October 7, 2008

FLEXTEND II

FDA Adverse Event
Death ·CPI - DEL CARIBE·Product code NVN·June 27, 2013

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·August 4, 2011

Quanta System Sterile Optical Laser Fiber, reusable

FDA Enforcement
Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026