14 results
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29ms
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Sources: EU EUDAMED, US FDA
Regenesis EMS Chair
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FPS
FDA UDI
Tyber Medical, LLC·00810040686160·Ø2.5mm Non-locking Screw, 26mm
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251026400·ceraMotion® Ti Base Dentin B1, 40 g / dental ce...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251026200·ceraMotion® Ti Base Dentin B1, 20 g / dental ce...
MARS HOLTER ANALYSIS WORKSTATION
FDA 510(k)
FDA Class 2
·Cardiovascular
sOLVe Tube
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
CLINITEK STATUS+
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016
NA
FDA UDI
aap Implantate AG·04042409445422·Cannulated Headless Bone Screw 2.5, L 26, TL 10...
NA
FDA UDI
aap Implantate AG·04042409194436·Cortical Screw 2.5, self-tapping, L 26
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 14, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 29, 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