28 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
FDA 510(k)
FDA Class 2
·Microbiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517636157·CoRoent Ant TLIF PEEK, 11x13x30mm 15°
5530 7L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021010·5530 SYR W/SMC ID TPR FM OUTLT
SILO
FDA UDI
AURORA SPINE, INC.·B5211133050·SILO, TAMP
PENUMBRA EMBOLIZATION COIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ENOXAPARIN TEST CARD
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2026
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 13, 2019
GRSPR,BLNT 3.4 MMSTR W/NR HNDL
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code NBH·May 10, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
LAMITRODE TRIPOLE 16
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 26, 2013
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC·Product code GAM·June 3, 2011
CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·August 12, 2008
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 3, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 29, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 4, 2020
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2022
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Recall
Terminated
·Lighthouse For The Blind·Product code LRR·March 22, 2013
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013