Elekta, Inc. - XiO RTP System - Class 2 Recall
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
View ArticleSiemens Healthcare Diagnostics, Inc - ADVIA Centaur Systems Phenytoin...
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA...
View ArticleSiemens Healthcare Diagnostics, Inc - ADVIA Centaur Systems Phenytoin...
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA...
View ArticleCareFusion 303, Inc. - Trifuse Extension Sets - Class 2 Recall
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
View ArticleStryker Medical Division of Stryker Corporation - Gaymar MediTherm - Class 2...
The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body...
View ArticleOssur Americas, Inc. - SYMBIONIC LEG - Class 2 Recall
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products...
View ArticleZest Anchors LLC - LOCATOR Implant Attachment System - Class 2 Recall
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use...
View ArticleITC-Nexus Dx - International Technidyne Corporation - Class 2 Recall
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low...
View ArticleOrthoPediatrics Corp - 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self...
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric...
View ArticleIntegra LifeSciences Corp. - Malibu Polyaxial Screwdriver - Class 2 Recall
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to...
View ArticleRTI Surgical, Inc. - OPTEFORM Allograft Paste - Class 2 Recall
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th...
View ArticleBio-Rad Laboratories, Inc. - D10 Dual Program, Update Kit D10 A1c program...
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...
View ArticleSiemens Healthcare Diagnostics, Inc. - Siemens ADVIA - Class 2 Recall
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high...
View ArticleOrtho-Clinical Diagnostics - enGen Laboratory Automation System - Class 2 Recall
enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative...
View ArticleOrtho-Clinical Diagnostics - enGen Laboratory Automation System - Class 2 Recall
enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro...
View ArticleSysmex America, Inc. - Sysmex UF1000i Automated Urine Particle Analyzer with...
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so...
View ArticleEcolab Inc - BUR HOLE LATEX PROBE COVER WITH GEL - Class 2 Recall
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
View ArticleEcolab Inc - BUR HOLE LATEX FREE PROBE COVER WITH GEL - Class 2 Recall
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
View ArticleEcolab Inc - BUR HOLE LATEX FREE PROBE COVER - Class 2 Recall
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
View ArticleEcolab Inc - BUR HOLE LATEX PROBE COVER WITH GEL - Class 2 Recall
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
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