33 results · 20ms · Sources: EU EUDAMED, US FDA

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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