11 results
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22ms
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Sources: EU EUDAMED, US FDA
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral life
FDA UDI
Merz Dental GmbH·D7091993520·anteriors; shade D4; mould UBS
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198369·AK3 PS Insert Trial Size 5, 20mm
GALAXY FIXATION SYSTEM
FDA UDI
ORTHOFIX SRL·18054242518709·GALAXY MEDIUM - PAEDIATRIC STERILE KIT - SCREW ...
EVA 15 Insufflator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VIVOSIGHT TOPICAL OCT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·March 7, 2013
ENDOPATH XCEL TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·February 16, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 8, 2014
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
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024