24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
VIDAS® FSH
FDA UDI
BIOMERIEUX SA·03573026156947·VIDAS® FSH (FSH) assay is a quantitative immuno...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481123726·LOCATOR R-Tx Attachment System, Straumann Tissu...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735527·Utility Scissors, 1 serrated blade, extra heavy...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128523·LOCATOR R-Tx Abutment, Straumann Tissue Level, ...
Summit Medical
FDA UDI
Summit Medical, Inc.·00385640068895·
NA
FDA UDI
Summit Medical, Inc.·00385640001168·
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Summit Medical, Inc.·00385640026741·
SHOCKPULSE LITHOTRIPSY TRANSDUCER.
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code FEO·January 29, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2023
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 8, 2013
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 27, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 22, 2011
VIDAS FSH, REF 30407-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code CGJ·September 22, 2021
VIDAS® FSH
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CGJ·July 19, 2022
VIDAS FSH, REF 30407-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS® FSH 60 TESTS
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CGJ·October 27, 2021
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020