15 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVANTAGE DRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
RMO
FDA UDI
Rmo, Inc.·00885797099754·LING RETNR BOND 4X4 6 CASE KIT
OPTEFORM® Allograft Full Disc, 3 x 20mm, 1cc
FDA UDI
Rti Surgical, Inc.·10885862093196·
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
FDA 510(k)
FDA Class 1
·Microbiology
ULTIMA METAL-ON-METAL ACETABULAR CUP
FDA 510(k)
FDA Class 3
·Orthopedic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013
PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DXE·January 28, 2011
6.0MM TI HARD ROD 400MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code KWP·February 26, 2008
ELEOS
FDA Adverse Event
Injury
·ONKOS SURGICAL·Product code KRO·November 4, 2021
ELEOS
FDA Adverse Event
Injury
·ONKOS SURGICAL·Product code KRO·November 4, 2021
ELEOS
FDA Adverse Event
Injury
·ONKOS SURGICAL·Product code KRO·November 4, 2021
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
FDA Enforcement
Class I
·Terminated·Abbott·May 23, 2018
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024