10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BETA
FDA UDI
Gc Orthodontics America Inc.·E53573K26017251·BETA-TITA KEYHOLE 17X25 26MM(5 PACK)(SO)
BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
FDA Adverse Event
Malfunction
·LEE LABORATORIES, INC.·Product code MDB·August 12, 2022
Citregen Tendon Interference Screw and Citrelock
FDA 510(k)
FDA Class 2
·Orthopedic
EndoFLIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALARIS SYSTEM PUMP MODULE
FDA Adverse Event
Injury
·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·December 10, 2008
TOTAL ASR FEM IMP SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·September 22, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 2, 2013
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
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020