19 results
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24ms
·
Sources: EU EUDAMED, US FDA
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
FDA 510(k)
FDA Class 2
·Cardiovascular
SCOTT'S SELECT K-FILES 6/pk 25mm # 06
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811225061·ENDODONTIC K-FILES (6/pack) Length: 25mm, Size:...
CancelleX™ 15mm x 13mm x 6mm x 12* Cervical Interbody
FDA UDI
XENCO MEDICAL LLC·B064XM3D31225061·
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MIXED MEDIA MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2009
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·March 8, 2013
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 12, 2012
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·September 22, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 13, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 2, 2015
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·March 14, 2013
SUPRA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 28, 2012
BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·September 25, 2019
Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300
FDA Recall
Terminated
·Teleflex Medical·Product code CCW·June 15, 2006
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024