SpineFrontier, Inc. - Rods Pedicle screw spinal system - Class 2 Recall
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they...
View ArticleStryker Instruments Div. of Stryker Corporation - CORE Universal Driver -...
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling,...
View ArticleStryker Instruments Div. of Stryker Corporation - TPS Universal Driver -...
Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone...
View ArticleStryker Instruments Div. of Stryker Corporation - REMB Universal Driver -...
RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE...
View ArticleIntegra LifeSciences Corporation - PANTA Arthrodesis Nail Support Device -...
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
View ArticleCodman & Shurtleff, Inc. - MedStream Programmable Infusion Pump - Class 1...
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or...
View ArticleCodman & Shurtleff, Inc. - MedStream Programmable Infusion Pump - Class 1...
MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of...
View ArticleTechnidata S.A. - TDHisto/Cytology - Class 3 Recall
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
View ArticleBoston Scientific Corporation - Alair Bronchial Thermoplasty Catheter - Class...
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation...
View ArticleEdwards Lifesciences, LLC - Edwards Lifesciences Suction Wand - Class 2 Recall
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical...
View ArticleSynthes USA HQ, Inc. - Class 2 Recall
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as...
View ArticleSiemens Medical Solutions USA, Inc - Siemens AXIOM Artis zee/zeego systems...
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
View ArticleStaar Surgical Co. - STAAR Surgical Afinity IOL - Class 2 Recall
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
View ArticleStaar Surgical Co. - STAAR Surgical nanoFLEX IOL - Class 2 Recall
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior...
View ArticleZeiss, Carl Inc - Polarizer D Fixed w/Rotating Red 1 lambda plate - Class 2...
Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
View ArticleBaxa Corporation - ExactaMix 1200 and 2400 Compounders - Class 2 Recall
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
View ArticleLeibel-Flarsheim Company LLC - Hydra Vision DR 60/80 System - Class 2 Recall
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
View ArticleHospira Inc. - LifeShield Symbiq Set - Class 2 Recall
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the...
View ArticleNational Biological Corp - Dermalight 80. UVB080 - Class 3 Recall
Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and...
View ArticleNational Biological Corp - Dermalight 80, UVB083 - Class 3 Recall
Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and...
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