78 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Endotine Transbleph 3.5 (CFD-080-0167)
FDA Enforcement
Class II
·Terminated·MicroAire Surgical Instruments, LLC·August 3, 2016
Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
FDA Recall
Terminated
·Coapt Systems, Inc.·Product code ---·May 23, 2003
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·November 15, 2017
Endotine Transbleph 3.5 (CFD-080-0167)
FDA Recall
Terminated
·MicroAire Surgical Instruments, LLC·Product code HWC·May 6, 2016
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Enforcement
Class II
·Terminated·Ziehm Imaging Inc·January 1, 2014
Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
FDA Recall
Terminated
·Andover Healthcare Inc.·Product code FQM·June 19, 2019
Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Recall
Terminated
·Andover Healthcare Inc.·Product code FQM·June 19, 2019
Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Recall
Terminated
·Andover Healthcare Inc.·Product code FQM·June 19, 2019
Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Recall
Terminated
·Andover Healthcare Inc.·Product code FQM·June 19, 2019
Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Recall
Terminated
·Andover Healthcare Inc.·Product code FQM·June 19, 2019
Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Recall
Terminated
·Andover Healthcare Inc.·Product code FQM·June 19, 2019
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.
FDA Enforcement
Class II
·Terminated·Hand Biomechanics Lab Inc·October 26, 2016
Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)
FDA Recall
Terminated
·Alcon Research, Ltd·Product code LQJ·September 2, 2005
Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345. Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters.
FDA Recall
Terminated
·St. Jude Medical·Product code IKD·June 1, 2011
St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA
FDA Recall
Terminated
·St. Jude Medical Atrial Fibrillation Division Inc·Product code OCL·June 15, 2009
Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.
FDA Recall
Terminated
·Hand Biomechanics Lab Inc·Product code JEC·September 14, 2016
DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code KDD·October 1, 2008
"***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Kit Contains: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; Gauze sponges; Extension tubing; Cholarprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code KDD·October 8, 2010
"***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" THIS KIT WAS DISCONTINUED. Kit Contained: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; 60ml syringe; Gauze sponges; Extension tubing; Chloraprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a TMJ arthrocentesis procedure.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code KDD·October 8, 2010