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