56 results · 30ms · 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.

Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.

FDA Recall
Terminated ·Baxter Healthcare Renal Div·Product code FKX·September 12, 2005

Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100

FDA Recall
Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. Sterile; made in USA; Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah, NJ 07430 A Subsidiary of Stryker Corp.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·August 30, 2007

DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G)

FDA Recall
Terminated ·Del Medical Systems Group·Product code IZL·October 3, 2006

Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5

FDA Recall
Terminated ·Home Access Health Corp (HAHC)·Product code MZO·October 6, 2006

Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009 Product Usage: Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers, clinicians and ancillary staff. Furthermore, Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs.

FDA Recall
Terminated ·Microsoft Corporation Health Solutions Group·Product code JQP·January 4, 2012

Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·December 15, 2014

Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.

FDA Recall
Terminated ·ConMed Corporation·Product code GEI·February 20, 2014

Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8063G (global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B; Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·May 3, 2005

Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D & 2M8064B; Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·May 3, 2005

HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM

FDA Recall
Terminated ·Porous Media Corporation·Product code BTT·April 26, 2007

Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

FDA Recall
Terminated ·Volcano Corporation·Product code KKX·February 5, 2016

Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

FDA Recall
Terminated ·Volcano Corporation·Product code KKX·February 5, 2016

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·January 7, 2022

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·January 7, 2022

Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·January 7, 2022