14 results
·
7ms
·
Sources: EU EUDAMED, US FDA
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
FDA Enforcement
Class III
·Terminated·Physio-Control, Inc.·March 16, 2022
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
FDA Enforcement
Class III
·Terminated·C.R. Bard, Inc.·August 17, 2016
inLight Medical LED Pads used with Polychromatic light technology system
FDA Enforcement
Class III
·Terminated·Inlightened Partners LLC·June 30, 2021
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·September 25, 2019
Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
FDA Enforcement
Class III
·Terminated·Cygnus Medical·April 20, 2016
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
FDA Enforcement
Class III
·Terminated·Teleflex Medical·January 22, 2020
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
FDA Enforcement
Class III
·Terminated·Teleflex Medical·January 22, 2020
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.
FDA Enforcement
Class III
·Terminated·Coloplast Manufacturing US, LLC·November 5, 2014
Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.
FDA Enforcement
Class III
·Terminated·Zoll Circulation, Inc.·July 30, 2014
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories·October 30, 2013
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories, Inc.·July 1, 2015
Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM
FDA Enforcement
Class III
·Terminated·Bio-rad Laboratories, Inc.·May 22, 2013
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories, Inc.·February 19, 2014