30 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERVENTIONAL BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741102905·Catheter Placement Kit
Councill Stylet
FDA UDI
C. R. Bard, Inc.·00801741049019·Councill Stylet
Synergy™ Ablation System
FDA UDI
ATRICURE, INC.·10840143900020·Glidepath Tape (3-Unit)
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282502294·TeWa CJ-Type 1630: coated acupuncture needles ...
TEWA
FDA UDI
asia-med GmbH·04251282509613·TeWa CJ-Type 1630: coated acupuncture needles ...
Synergy™ Ablation System
FDA UDI
ATRICURE, INC.·00818354010718·Glidepath Tape (3-Unit)
LIFEPAK® 12 defibrillator/monitor
FDA UDI
PHYSIO-CONTROL, INC.·00721902149115·LP12AABBABAABBABAAAAAAAALP12 MONITOR-DEFIB
UniTip Catheter
FDA UDI
Unisensor AG·07640172971529·
MONOFILAMENT BIOSYN SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENHANCED COMPENSATING FILTER
FDA 510(k)
FDA Class 2
·Radiology
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 4, 2023
SPINNING SPIROS CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·February 2, 2021
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·August 13, 2010
CAST CUTTER, 8 FOOT CORD "
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAB·March 12, 2013
TALENT ABDOMINAL EXTENSION CUFF
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 18, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP.·Product code LGW·February 21, 2008
SPINNING SPIROS CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·February 10, 2021
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