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Teleflex Medical - RUSCH TruLite - Class 2 Recall

RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.

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Small Bone Innovations - Class 2 Recall

Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of...

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Brainlab AG - Brainlab Diital Lightbox - Class 2 Recall

The Patient Data Manager (Digital Lightbox) is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file...

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Zimmer, Inc. - Zimmer Periarticular Locking Plate System - Class 2 Recall

Zimmer¿ Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only), Zimmer, Inc., 345 E. Main Street, Warsaw, Indiana 46582 Temporary internal...

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Nidek Inc - MC500 Multicolor Laser Photocoagulator - Class 2 Recall

MC 500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Fremont, CA: Manufactured by NIDEK CO., Ltd, 34 14 Maehama, Hiroishi cho, Gamagori, Aichi 4430038, Japan. The Nidek Multicolor Laser...

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Wellspring Pharmaceutical Corporation - IPM Wound Gel - Class 1 Recall

IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.

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Carestream Health Inc. - INSIGHT Dental Film - Class 3 Recall

INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Rochester, NY 14608

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Carestream Health Inc. - Ultraspeed Dental Film - Class 3 Recall

Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Rochester, NY 14608

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Market-Tiers Inc - Instructions for Use for the blue endo moresolution...

Instructions for Use for the blue endo moresolution Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.

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X Spine Systems Inc - Serrated Soft Tissue Shields - Class 2 Recall

Serrated Soft Tissue Shields are surgical instruments and packaged as part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint...

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Advandx Inc - AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures) -...

AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number:...

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Ortho-Clinical Diagnostics - VITROS 4600 Chemistry System - Class 2 Recall

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical...

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Ortho-Clinical Diagnostics - VITROS 5600 Integrated System - Class 2 Recall

VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products...

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Ortho-Clinical Diagnostics - VITROS 3600 Immunodiagnostic System - Class 2...

VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic...

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Carestream Health Inc. - KODAK DirectView DR 9000 System - Class 2 Recall

KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an...

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Zimmer, Inc. - TaperedScrew Vent Implant - Class 2 Recall

Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8

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Brainlab AG - Brainlab ExacTrac - Class 2 Recall

ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to...

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Boston Scientific CRM Corp - ENDOTAK RELIANCE SG - Class 2 Recall

Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver...

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Teleflex Medical - RUSCH Foley Insertion Tray - Class 3 Recall

RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

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BioMerieux SA - VIDAS Total Prostate Specific Antigen - Class 2 Recall

VIDAS TPSA intended for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.

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