75 results · 12ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

FDA Recall
Open, Classified ·Zimmer Surgical Inc·Product code FZW·January 2, 2024

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

BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.

FDA Recall
Open, Classified ·Straight Smile, LLC·Product code NXC·November 4, 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

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

daVinci Harmonic ACE Curved Shears

FDA Recall
Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·January 16, 2019

Virus Counter Platform with Model Name VC3100

FDA Recall
Open, Classified ·Sartorius Corporation·Product code REQ·March 11, 2022

Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

FDA Recall
Open, Classified ·Argon Medical Devices, Inc·Product code DYB·July 8, 2021

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code DXN·August 30, 2024

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code DXN·August 30, 2024

MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code DXN·August 30, 2024

RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·September 22, 2021

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

FDA Recall
Open, Classified ·Medtronic Perfusion Systems·Product code DWF·August 6, 2025

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

FDA Recall
Open, Classified ·Medtronic Perfusion Systems·Product code DWF·August 6, 2025

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

FDA Recall
Open, Classified ·Medtronic Perfusion Systems·Product code DWF·August 6, 2025

EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.

FDA Recall
Open, Classified ·Product code HSX·June 19, 2020