30 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
3.0MM CANNULATED SCREW LONG THREAD/34MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·February 19, 2013
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221115089·3M™ Victory Series™ First Molar Bands Kit, Lowe...
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NON/GEL ADHESIVE DISPERSIVE ELECTRODE 3427,33-4270
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 23, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 24, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013
SIGNATURE PACK, DISPOSABLE TUBING
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·December 14, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 22, 2014
Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm
FDA Recall
Terminated
·Orthopedic Alliance LLC·Product code KWY·February 20, 2013
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
FDA Recall
Terminated
·Orthopedic Alliance LLC·Product code HWC·February 20, 2013
50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Recall
Terminated
·Spinal Solutions, LLC·Product code MNI·February 20, 2013
40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Recall
Terminated
·Spinal Solutions, LLC·Product code MNI·February 20, 2013
Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Recall
Terminated
·Spinal Solutions, LLC·Product code KWQ·February 20, 2013
Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Recall
Terminated
·Spinal Solutions, LLC·Product code MNI·February 20, 2013
60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Recall
Terminated
·Spinal Solutions, LLC·Product code MNI·February 20, 2013
45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Recall
Terminated
·Spinal Solutions, LLC·Product code MNI·February 20, 2013
50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Recall
Terminated
·Spinal Solutions, LLC·Product code MNI·February 20, 2013
Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long
FDA Recall
Terminated
·Orthopedic Alliance LLC·Product code LZO·February 20, 2013