9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
SPYROFOAM WOUND DRESSING
FDA 510(k)
FDA Class 1
·General Hospital
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106150·HOSKIN #30 COLIBRI FORCEPS
MATRIX HOLTER SYSTEM, MODEL M12
FDA 510(k)
FDA Class 2
·Cardiovascular
Magellan Robotic System
FDA 510(k)
FDA Class 2
·Cardiovascular
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·February 9, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 6, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 23, 2014
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent.
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company, BD Biosciences·July 24, 2024
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