12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AccuFit Lateral 2-Hole Plate
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578570·CoRoent Ant TLIF Ti, 12x10x32mm 4°
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824487·Walther Female Dilator-Catheters 13cm, 24Fr
NHancer Rx
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFESTYLE OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·March 1, 2018
PRECISION XTRA / OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 31, 2008
ON-Q, 400ML, 2-14ML/HR SELECT-A-FLOW, PUMP
FDA Adverse Event
Injury
·I-FLOW CORP.·Product code MEB·August 16, 2011
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
ARROW Endurance Extended Dwell Peripheral Catheter System
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025