24 results · 11ms · Sources: EU EUDAMED, US FDA

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Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. Haag-Streit USA, Inc. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal.

FDA Recall
Terminated ·Haag-Streit USA Inc·Product code HJB·June 20, 2011

Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.

FDA Recall
Terminated ·Haag-Streit USA Inc·Product code HJB·November 14, 2011

CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

FDA Recall
Terminated ·Centers For Disease Control and Prevention·Product code OZE·April 26, 2024

HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.

FDA Recall
Terminated ·ASO, LLC·Product code MGO·July 26, 2013

Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.

FDA Recall
Terminated ·Newport Medical Instruments Inc·Product code CBK·January 13, 2009

Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)

FDA Recall
Terminated ·Newport Medical Instruments Inc·Product code CBK·May 14, 2010

Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. Sold under the following brand names: Family Dollar HomeBest HEB Meijer Food Lion health PRIDE Stop and Shop Super G sunmark Brite-Life Wegmans Our Family Healthy Generations GoodSense Winn Dixie Finast Western Family K C Pharmaceuticals

FDA Recall
Terminated ·K C Pharmaceuticals Inc·Product code LPN·October 4, 2004

Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B Product Code: NOU The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22Ibs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation. The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

FDA Recall
Terminated ·Newport Medical Instruments Inc·Product code CBK·July 22, 2009

Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011

Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories.

FDA Recall
Terminated ·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008

Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011

Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.

FDA Recall
Terminated ·Biomet 3i, Inc.·Product code EJB·May 9, 2008

Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.

FDA Recall
Terminated ·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008

Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

FDA Recall
Terminated ·Zimmer Surgical Inc·Product code HAB·October 6, 2014