11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET
FDA 510(k)
FDA Class 2
·Cardiovascular
Barco
FDA UDI
Barco NV·05415334033115·Surgical color monitor
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102695·MINARDI PHACO CHOPPER
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
Percutaneous Nephroscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THORACOPORT 10.5MM TROCAR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC·Product code GCJ·January 7, 2013
DURATA STS OPTIM PASSIVE FIXATION
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 17, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2014
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 15, 2022
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 15, 2022
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019