33 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NOVA CORDLESS CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
Affiniti
FDA UDI
TORNIER, INC.·00846832022588·LATERAL CUT GUIDE - CUT BLOCK
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741091285·Catheter Placement Kit
TEWA
FDA UDI
asia-med GmbH·04251282508593·TeWa 5CB-Type 2025 Speed Pak: coated acupunctu...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501273·TeWa 5CB-Type 2025 Speed Pak: coated acupunctu...
intellijoint HIP®
FDA UDI
Intellijoint Surgical Inc·00628184003930·Pelvic Platform, Mini
GeneXpert Dx System
FDA UDI
CEPHEID·07332940004040·XPERT, GENEXPERT DX SYSTEM
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522131370·ECLIPSE PRO,DEFIB CABLE,PX,4 SNAP,LONG,UKCA
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129704·ECLIPSE PRO,DEFIB CABLE,PX,4 SNAP,LONG
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
FDA 510(k)
FDA Class 2
·Cardiovascular
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 5, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2021
TUFF PRO IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 30, 2025
EVIS EXERA III DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·August 29, 2024
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 12, 2013
TRIDENT HEMISPHERICAL CLUSTER 50MM
FDA Adverse Event
Other
·STRYKER ORTHOPAEDICS CORK·Product code MEH·February 9, 2011
LCS COMPLETE M/B PAT CEM STD+
FDA Adverse Event
Injury
·DEPUY-CORK A DIV OF DEPUY ORTHOPAEDICS·Product code NJL·February 19, 2008
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView XCT (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