11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Trocar
FDA UDI
SOPRO-COMEG GmbH·04059082005447·
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
REVERS BROACH/TRIAL, SIZE 5 MODULAR
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·April 2, 2025
VERSAFITCUP HIGHCROSS LINER
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MEH·October 26, 2011
VITEK® 2 AST-ST01 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·October 24, 2017
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·April 29, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·August 12, 2008
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021