189 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEMORRHAGE OCCLUDER PIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040109·RING PESSARY-SUPPORT #9
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00401091·
BiomarC®
FDA UDI
Carbon Medical Technologies, Inc.·00858015005127·Carbon Tissue Marker System, kV
BiomarC®
FDA UDI
Carbon Medical Technologies, Inc.·00858015005523·Fiducial Marker System, kV
LEONE SPA
FDA UDI
LEONE SPA·08033707002031·BIOSTEEL WIRE SPRING HARD 0,9mm
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
FDA 510(k)
FDA Class 2
·Hematology
FLUOROPERM 151-OK, PARAGON HDS 100-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742112190·LYNX Distal Humeral Locking Plate Medial Anatom...
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023124·B-P HIP FEMORAL STEM W/O HEAD, W/ BIOCOAT & ULT...
CONCERTO
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·April 3, 2013
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 5, 2011
CORAIL2 STD SIZE 11
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code KWA·May 7, 2008
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 5, 2025
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 20, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026