59 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
FDA Recall
Open, Classified
·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
FDA Recall
Open, Classified
·Neuralynx Inc·Product code GXY·March 14, 2022
Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
FDA Recall
Open, Classified
·Product code KWP·September 16, 2019
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
FDA Recall
Open, Classified
·DeRoyal Industries Inc·Product code NAC·May 18, 2026
Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
FDA Recall
Open, Classified
·Product code KWP·September 16, 2019
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Recall
Open, Classified
·DRG International, Inc.·Product code KLI·October 18, 2021
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)
FDA Recall
Open, Classified
·AMO Manufacturing USA, LLC·Product code OOE·October 21, 2021
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
FDA Recall
Open, Classified
·AMO Manufacturing USA, LLC·Product code LZS·October 21, 2021
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
FDA Recall
Open, Classified
·DeRoyal Industries Inc·Product code LRO·December 12, 2022
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 3, 2022
Model A710 Intellis Clinician Programmer Application, version 2.0.97
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 19, 2023
Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·May 16, 2024
Vanta Implantable Neurostimulator (INS), Model 977006
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·August 21, 2024
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·June 21, 2023
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·July 18, 2023
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·July 18, 2023