13 results
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21ms
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Sources: EU EUDAMED, US FDA
DATA-ZYME UREA NITROGEN, COLORIMETRIC
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sphero Attachments
FDA UDI
Preat Corporation·00842092123089·Sphero Block Abutment Ankylos 4.5 x 0mm (1.8mm ...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209131150·
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031667·Rhoton® Needle Holder, Curved Tip, Titanium, 7 in
ACUMED
FDA UDI
Acumed LLC·10806378051173·ARH Head Removal Tool Fork Assy
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580172700001·SURE-SNAP 2. MOLAR UPR RGT SZ 27
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEATHCARE CORP·Product code FRN·January 8, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 27, 2007
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 28, 2015
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022