22 results · 8ms · 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.

Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Kit BD Max MRSA; Catalog # 442953

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.

FDA Enforcement
Class II ·Terminated·Bausch & Lomb Inc·October 3, 2018

Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

FDA Enforcement
Class II ·Terminated·Cook Inc.·April 4, 2018

EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.

FDA Enforcement
Class II ·Ongoing·RESPIRATORY THERAPEUTICS GROUP LLC·March 11, 2020

VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

FDA Enforcement
Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc·May 25, 2022

Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

FDA Enforcement
Class II ·Terminated·Remel Inc·May 29, 2019

EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

FDA Enforcement
Class II ·Terminated·Remel Inc·May 29, 2019

Set-Up Pack, part number PSS1305(C

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

FDA Enforcement
Class II ·Terminated·Remel Inc·May 29, 2019

BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.

FDA Enforcement
Class II ·Terminated·Bausch & Lomb Inc Irb·November 11, 2015

Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

FDA Enforcement
Class II ·Terminated·Remel Inc·May 29, 2019