14 results
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6ms
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Sources: EU EUDAMED, US FDA
PerkinElmer 226 Sample Collection Device
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·June 10, 2020
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
FDA Enforcement
Class III
·Terminated·Becton, Dickinson and Company, BD Biosciences·April 20, 2016
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience, Inc.·August 3, 2016
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
FDA Enforcement
Class III
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·August 2, 2017
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
FDA Enforcement
Class III
·Terminated·Dannoritzer Medizintechnik GmbH & Co. KG·October 10, 2018
Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
FDA Enforcement
Class III
·Terminated·Berchtold Corp.·August 15, 2012
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
FDA Enforcement
Class III
·Terminated·Euro Diagnostica AB·July 5, 2017
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
FDA Enforcement
Class III
·Ongoing·Boston Scientific Corporation·January 16, 2019
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·December 28, 2016
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
FDA Enforcement
Class III
·Ongoing·Boston Scientific Corporation·January 16, 2019
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional.
FDA Enforcement
Class III
·Ongoing·Zyno Medical LLC·December 4, 2024
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015
IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
FDA Enforcement
Class III
·Ongoing·Boston Scientific Corporation·January 16, 2019