344 results · 19ms · 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.

Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

Philips Odyssey LX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.

FDA Recall
Terminated ·Vistakon·Product code LPL·April 20, 2009

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

FDA Recall
Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444

FDA Recall
Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.

FDA Recall
Terminated ·Cook Inc.·Product code KRA·October 21, 2015

IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

FDA Recall
Terminated ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code OMB·December 2, 2021

AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·March 6, 2015

Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.

FDA Recall
Terminated ·Zimmer, Inc.·Product code JDC·November 19, 2012

Soft Contact Lens

FDA Recall
Terminated ·Cooper Vision Caribbean Corp.·Product code LPM·October 28, 2014

AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA

FDA Recall
Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LPS·August 22, 2003

AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255

FDA Recall
Completed ·Beckman Coulter Inc.·Product code JQP·January 19, 2018

COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.

FDA Recall
Terminated ·Zimmer, Inc.·Product code JDC·November 19, 2012

Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

FDA Recall
Terminated ·Hologic, Inc.·Product code JAA·September 14, 2012

Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

FDA Recall
Terminated ·Hologic, Inc.·Product code JAA·September 14, 2012

TECNIS Toric II OptiBlue IOL Models ZCW

FDA Recall
Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code MJP·December 12, 2023

Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.

FDA Recall
Terminated ·SpineFrontier, Inc.·Product code HXX·May 9, 2012

Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

FDA Recall
Open, Classified ·Alcon Research LLC Aspex Facility·Product code FWJ·May 23, 2024

Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.

FDA Recall
Terminated ·Vistakon·Product code LPM·July 16, 2010