14 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 STERNAL ZIPFIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST Men's Dress
FDA UDI
BSN MEDICAL, INC.·00035664107895·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE MED...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818370·AXS Segmented Rings- Round, Medium, Pair, 10.5"
Leva® Anterior Expandable Spacer System
FDA UDI
Spine Wave, Inc.·10840642109351·Spacer, 38 mm (W) x 30 mm (D) x 19 mm (H), 8° L...
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
FDA 510(k)
FDA Class 2
·Cardiovascular
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022
ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code OZO·September 23, 2014
UNICEL® DXC 600 PRO® SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 1, 2011
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024