10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155
FDA 510(k)
FDA Class 2
·Orthopedic
KIMTECH STERLING NITRILE EXAM GLOVES (M)
FDA UDI
KIMBERLY-CLARK GLOBAL SALES, LLC·00036019507070·Examination Gloves
KIMTECH STERLING NITRILE EXAM GLOVES (M)
FDA UDI
KIMBERLY-CLARK GLOBAL SALES, LLC·00036000507072·Examination Gloves
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NURSE'S ASSISTANT O.R. CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 22, 2013
SURESTEP ONE STEP HCG PREGNANCY TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·April 14, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018