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Sources: EU EUDAMED, US FDA
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Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·August 31, 2020
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 28, 2020
BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Enforcement
Class II
·Terminated·BIOTRONIK Inc·April 28, 2021
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Enforcement
Class II
·Terminated·BIOTRONIK Inc·April 28, 2021
BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code LWS·March 8, 2021
Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code NBC·April 5, 2012
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NCF·June 30, 2017
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NCF·June 30, 2017
STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
FDA Recall
Terminated
·HF Acquisition Co., LLC·Product code LRR·June 4, 2020
STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.
FDA Recall
Terminated
·HF Acquisition Co. LLC·Product code LRR·June 5, 2020
STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
FDA Recall
Terminated
·HF Acquisition Co., LLC·Product code LRR·June 4, 2020
STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
FDA Recall
Terminated
·HF Acquisition Co., LLC·Product code LRR·June 4, 2020
HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300
FDA Recall
Terminated
·HF Acquisition Co., LLC·Product code LRR·June 4, 2020
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.
FDA Enforcement
Class II
·Terminated·Ossur H / F·April 6, 2016
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2 ) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30
FDA Enforcement
Class II
·Terminated·Ossur H / F·March 25, 2015
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
FDA Enforcement
Class II
·Terminated·Ossur H / F·April 6, 2016
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
FDA Enforcement
Class II
·Terminated·Ossur H / F·April 6, 2016
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
FDA Enforcement
Class II
·Terminated·Ossur H / F·April 6, 2016
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
FDA Enforcement
Class II
·Terminated·Ossur H / F·April 6, 2016