21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PARIETEX OPTIMIZED COMPOSTIE MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743625·LEVAMED ANKLE SUPPORT SAND V
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK110151·DD tempMED are pre-colored dental milling blank...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818578·Malleable Retractor 2" x 7" w/ Protective Edge
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046711·
Tecno
FDA UDI
TECNO INSTRUMENTS (PVT) LTD·08964000209851·Metzenbaum Bipolar Scissors 7” (18.0 cm), Insul...
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
FDA 510(k)
FDA Class 2
·Cardiovascular
NTERO NOMAD SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DONJOY
FDA UDI
DJO, LLC·00888912015332·COLD PAD,ANKLE FOAM,S,RH
HAND CONTROLLED PENCIL
FDA Adverse Event
Other
·CONMED·Product code GEI·February 7, 2012
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 12, 2026
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023
EONC
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
2.0/2.5MM DRIVER BIT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HTW·September 23, 2014
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 1, 2011
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024