444 results · 22ms · 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.

PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.

FDA Recall
Terminated ·Merz North America, Inc.·Product code MIX·October 26, 2015

DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.

FDA Recall
Terminated ·Musculoskeletal Transplant Foundation, Inc.·Product code MQV·December 4, 2014

Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.

FDA Recall
Terminated ·Baxa Corporation·Product code LHI·May 8, 2009

GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05

FDA Recall
Terminated ·GE Medical Systems Information Technologies·Product code LLZ·July 18, 2005

Exacta-Mix 2400 pharmacy compounding system.

FDA Recall
Terminated ·Baxa Corporation·Product code NEP·November 7, 2003

Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

FDA Recall
Terminated ·Valeant Pharmacueticals International·Product code N/A·January 29, 2016

iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

FDA Recall
Terminated ·Conformis, Inc.·Product code LPH·August 22, 2019

iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

FDA Recall
Terminated ·Conformis, Inc.·Product code LPH·August 22, 2019

Exacta-Mix Valve Set, Primary Valve Assembly

FDA Recall
Terminated ·Baxa Corporation·Product code LHI·April 30, 2004

CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS

FDA Recall
Terminated ·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021

Exacta-Mix Valve Set, Primary Valve Assembly

FDA Recall
Terminated ·Baxa Corporation·Product code LHI·April 30, 2004

Exacta-Mix Valve Set, Secondary Valve Assembly

FDA Recall
Terminated ·Baxa Corporation·Product code LHI·April 30, 2004

Exacta-Mix Valve Set, Primary Valve Assembly, Pediatric

FDA Recall
Terminated ·Baxa Corporation·Product code LHI·April 30, 2004

Exacta-Mix Valve Set, Six Inlet, Tubing Kit

FDA Recall
Terminated ·Baxa Corporation·Product code LHI·April 30, 2004

CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051

FDA Recall
Terminated ·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021

VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code JRB·October 10, 2013

Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled

FDA Recall
Terminated ·Baxa Corporation·Product code LHI·April 30, 2004

Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·February 6, 2015

AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

FDA Recall
Terminated ·Tosoh Bioscience Inc·Product code KHO·September 28, 2017

Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube

FDA Recall
Terminated ·Baxa Corporation·Product code LHI·April 30, 2004