Omnyx Llc - Digital Pathology System (DPS) Software, version 1.1 - Class 2...
Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning,...
View ArticleArrow International Inc - Arrow Transradial Artery Access products - Class 2...
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
View ArticleCutera, Inc. - truSculpt - Class 2 Recall
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is...
View ArticleSynthes USA HQ, Inc. - Synthes TomoFix Plates - Class 2 Recall
Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur,...
View ArticleBeckman Coulter Inc. - Coulter LH 750 Hematology Analyzer - Class 2 Recall
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter...
View ArticleBeckman Coulter Inc. - Coulter LH 780 Hematology Analyzer - Class 2 Recall
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter...
View ArticleSynthes USA HQ, Inc. - Synthes Trochanteric Fixation Nail - Class 2 Recall
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
View ArticleZimmer, Inc. - Zimmer Trabecular Metal Total Ankle Tibial Base and Talar...
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving...
View ArticleZimmer, Inc. - Zimmer Trabecular Metal Total Ankle Tibial Base and Talar...
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving...
View ArticleZimmer, Inc. - Zimmer Trabecular Metal Total Ankle Tibial Base and Talar...
Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving...
View ArticleStryker Howmedica Osteonics Corp. - Stryker Orthopaedics - Class 2 Recall
Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France...
View ArticleSteris Corporation - AMSCO Evolution steam sterilizer Transfer Carriage -...
AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.
View ArticleZimmer, Inc. - NexGen Complete Knee Solutions Stemmed Tibial Component...
NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is...
View ArticleAccumetrics Inc - VerifyNow IIb/IIIa Test, 10Test Kit - Class 2 Recall
VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure...
View ArticleAesculap, Inc. - Aesculap GNI161 Bipolar Foot Control - Class 2 Recall
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in...
View ArticleTrumpf Medical Systems, Inc. - Helion S Exam Light or H300 - Class 2 Recall
Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
View ArticleGE Healthcare, LLC - HGE Healthcare Patient Monitor B30, Procare Monitor B20,...
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for...
View ArticleStryker Neurovascular - GDC10 ULTRASOFT 2MM X 3CM - Class 2 Recall
Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior...
View ArticleStryker Neurovascular - EXCELSIOR SL10 PRESHAPED J 15OCM - Class 2 Recall
Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA...
View ArticleStryker Neurovascular - EXCELSIOR SL10 PRESHAPED J 15OCM - Class 2 Recall
Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA...
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