22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABBOTT CARBAMAZEPINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138127296·BICRO KNEE IMMOBILIZER W/PATELLA STRAP 18" UN
ADVIA Centaur® CA 19-9 MCM
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414447926·CA19-9 master material - CENTAUR - CONS
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540492050·LOCKING SCREW, CROSS-PIN
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376657141·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 18mm
Complete Cervical
FDA UDI
Seaspine Orthopedics Corporation·10889981040789·Screw - Self-Drilling - 3.5x18mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197381550·CERA-CUT® TC Reynolds Scissors
curved...
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376536194·SPS VA Self-Drill Screw, 3.5 x 18 mm
Sochi
FDA UDI
Altus Spine, LLC·00843210166476·Polyaxial Screw,3.5mm x 18mm
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052362·3.5mm x 18mm Poly Screw Assm. The Atoll OCT Spi...
TRINITY ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ECAT LSO PET/CT 16
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
VNS PULSE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 9, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 8, 2011
VALEO / VALEO II
FDA Adverse Event
Malfunction
·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
ULTRAFLEX DUO HIGH FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 28, 2017
BARDIA® FOLEY CATHETER SILICONE COATED
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·October 19, 2022