13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zimmer Periarticular Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
HYPERQ AD-100 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ELEVATE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·July 8, 2020
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABS.·Product code FTL·April 4, 2013
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 26, 2014
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 21, 2011
BD LUER-LOK¿ 1-ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 20, 2023
BD NEXIVA CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 1, 2020
BD NEXIVA DUAL PORT WITH CAP 20GA 1.00IN (1.1 MM X 25 MM)
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 18, 2019
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code CBK·April 18, 2022
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·June 15, 2016
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022