14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RIA KIT, VITAMIN B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dealmed
FDA UDI
DEALMED MEDICAL SUPPLIES LLC·00817415020215·Tongue Depressor Sterile Wood 6" Senior 1's, 10...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111297250·JACKSON TRACH TUBE #4-4 PIECES
KING Snap Lead/DIN Connector
FDA UDI
Kego Corporation·00663427000048·KING Snap Lead/DIN Connector Qty 5
.6 m (24")...
RX LENS SERIES
FDA 510(k)
FDA Class 1
·Ophthalmic
Dissecting Balloon System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1020279-2014-00289
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·April 30, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·January 24, 2008
4K C-MNT SCP,4.0,0,167,MITEK
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code HRX·May 23, 2024
UNKNOWN SOLITAIRE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·January 8, 2025
UNKNOWN SOLITAIRE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·January 8, 2025
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·November 12, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021