12 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HRS·September 3, 2021
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 13, 2021
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HXX·April 15, 2021
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·June 9, 2021
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Recall
Terminated
·Water Pik, Inc.·Product code JET·July 2, 2018
Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.
FDA Recall
Terminated
·Water Pik, Inc.·Product code KMA·April 3, 2012
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Enforcement
Class II
·Terminated·Water Pik, Inc.·August 15, 2018
3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code LWK·January 14, 2019
Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.
FDA Recall
Terminated
·Medline Industries Inc·Product code LWK·July 8, 2015
3M Surgical Clipper Professional 9681
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code LWK·February 2, 2018
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
FDA Recall
Terminated
·XTANT Medical·Product code PEK·December 29, 2021
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code PQK·April 12, 2019