Siemens Medical Solutions USA, Inc - Siemens Artis Zee Family - Class 2 Recall
Artis Zee Angiographic x-ray systems.
View ArticleRAYSEARCH LABORATORIES AB - RayStation - Class 2 Recall
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
View ArticlePhilips Medical Systems (Cleveland), Inc. - Pinnacle3 Radiation Therapy...
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013 Pinnacle3 Radiation Therapy Planning System is a computer software package intended to...
View ArticleZOLL Medical Corporation - Zoll Medical X Series/PropaqMD/PropaqM...
Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher The X Series is intended for use by trained medical personnel who are familiar...
View ArticleInfantino LLC - Class 2 Recall
Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring.
View ArticleAllesee Orthodontic Appliances - Distalizer Lock Nut Screw - Class 2 Recall
Distalizer Lock Nut Screw. The brand name of the device is the Distalizer Lock Nut Screw. The Distalizer Lock Nut screw, a component of customized devices used to widen a patient's arch and/or move...
View ArticleOrmco/Sybronendo - Titanium Orthos Brackets - Class 2 Recall
Titanium Orthos Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.022 +9/+9/0, Part Number 449-6212, Lot Number 121359169.Titanium Orthos Brackets are a...
View ArticleTeleflex Medical - 10mm Weck Vista Cannula - Class 2 Recall
10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow...
View ArticleTeleflex Medical - 5/10 mm Weck Vista Universal Cannula - Class 2 Recall
5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination,...
View ArticleTeleflex Medical - 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access...
5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories...
View ArticleTeleflex Medical - Weck Vista Universal Laparoscopic Port - Class 2 Recall
Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic...
View ArticleTeleflex Medical - 5/10 Weck Vista Universal Balloon Open Access Port - Class...
5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck...
View ArticleTeleflex Medical - 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access -...
5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of...
View ArticleStryker Howmedica Osteonics Corp. - Class 2 Recall
Stryker Orthopaedics Product Usage: The citation TMZF HA stem is indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular...
View Article3M Company - Health Care Business - 3M SteriVac Gas Sterilizer/Aerators -...
3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas...
View ArticleRoche Diagnostics Operations, Inc. - Omni Microelectrode for cobas b221...
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2....
View ArticleSiemens Medical Solutions Diagnostics - Class 2 Recall
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine...
View ArticleElekta, Inc. - Integrity 1.1. - Class 2 Recall
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation...
View ArticleSiemens Medical Solutions USA, Inc. - ACUSON P300 Ultrasound system with P300...
ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe. ACUSON P300 is the Siemens brand name for Esaote product 7348, for which Esaote has the 510k. Esaote is a Siemens OEM manufacturer....
View ArticleMerit Medical Systems, Inc. - Merit Custom Syringe Kit - Class 2 Recall
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010, Sterile EO, 15 Units Product Usage: Merit Medical Custom Syringe Kit is a combination of legally marketed medical devices...
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