33 results
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20ms
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Sources: EU EUDAMED, US FDA
MDA D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004028·PowerChem Neoprene Exam Gloves, Small
Poly Per-Q-Cath
FDA UDI
Bard Access Systems, Inc.·00801741100215·Catheter Placement Kit
TEWA
FDA UDI
asia-med GmbH·04251282511173·TeWa CJ-Type 2250(s) Safe-T Sleeve: uncoated a...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282503857·TeWa CJ-Type 2250(s) Safe-T Sleeve: uncoated a...
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004920·
CURE ACP
FDA UDI
SpineArt SA·07640270065878·ANTERIOR CERVICAL PLATE, 4 LEVELS L92
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640375231864·CERVICAL 4 LEVEL TEMPLATE L92
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640375234285·ANTERIOR CERVICAL PLATE, 4 LEVELS L92
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004920·
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·June 3, 2024
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·March 12, 2013
BREEZE2 TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·January 31, 2011
VITALITY VR
FDA Adverse Event
Malfunction
·CLONMEL·Product code LWS·February 8, 2008
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012