24 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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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
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
FDA Recall
Open, Classified
·Zimmer Surgical Inc·Product code FZW·January 2, 2024
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·June 17, 2024
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·November 4, 2021
Medtronic InterStim Ground Pad REF 041826
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·July 6, 2023
Enhanced Verify Evaluation Handset (CFN HH90130FA)
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·April 3, 2025
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·May 15, 2019
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
FDA Recall
Open, Classified
·Molnlycke Health Care, Inc·Product code FZW·April 24, 2017
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·February 28, 2022
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