24 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTERDRY SILVER
FDA 510(k)
FDA Class 1
·General Hospital
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000887964·CROSSLINK 8110715 ANTERIOR 15MM
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902844751·CROSSLINK 8110715 ANTERIOR 15MM
STARLED5 NX
FDA UDI
ACEM SPA·08050705890583·STARLED5 NX 3-ARM CEILING MODULAR LINE w/OTHER ...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK110151·DD tempMED are pre-colored dental milling blank...
Ormco
FDA UDI
ORMCO CORPORATION·00889989028577·SS BROAD ARCH LO LGE 0210X0250 PK/10
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803390·Post Coupler, 1" Ø
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046636·
NEEDLE SFTYGLD 25X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·August 22, 2019
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742122427·DRACO MetaFuse Plantar Plate, Ti - (L)40mm, R
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AL-40
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·November 15, 2024
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
UNKNOWN DEPUY HIP LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·June 1, 2011
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
BD SYRINGE 10ML REG PR SALINE FILL SPKG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 20, 2023