24 results
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6ms
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Sources: EU EUDAMED, US FDA
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 7, 2015
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.
FDA Enforcement
Class II
·Terminated·Tec Com Gmbh·November 20, 2019
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·February 27, 2019
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·July 5, 2017
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·October 31, 2018