36 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQL·November 19, 2009
Agendia MammaPrint, Catalog Numbers MP01, MP US version 03
FDA Recall
Terminated
·Agendia Inc·Product code NYI·March 3, 2010
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
FDA Enforcement
Class II
·Terminated·Brainlab AG·August 19, 2020
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
FDA Enforcement
Class II
·Terminated·Brainlab AG·August 19, 2020
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code HAW·June 9, 2009
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
FDA Enforcement
Class II
·Terminated·Northern Digital Inc.·July 22, 2015
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
FDA Enforcement
Class II
·Terminated·Northern Digital Inc.·July 22, 2015
Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101
FDA Recall
Terminated
·Propper Mfg Co Inc·Product code JOJ·February 7, 2008
VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LEG·April 18, 2005
NDI Combo Test Pak Omega 3, Product K7616, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
NDI/Life Extension Microtainer Blood Kit, Product K7625, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
NDI Combo Test Pak Omega 3, Product K7618, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
FDA Recall
Terminated
·Northern Digital Inc. 103 Randall Drive Waterloo Canada Ontario·Product code HAW·June 10, 2015
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
FDA Recall
Terminated
·Northern Digital Inc. 103 Randall Drive Waterloo Canada Ontario·Product code HAW·May 20, 2015
Heritage Labs Nutrasource NDI (USA) DBS Kit, Product K7610, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code KDT·January 9, 2011
ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
FDA Recall
Terminated
·Acrymed Incorporated·Product code FRO·June 30, 2008
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Enforcement
Class II
·Terminated·Neuro Kinetics, Inc.·September 9, 2015
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016
i-STAT cTnI cartridge
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code MMI·October 16, 2019