21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
FDA 510(k)
FDA Class 2
·Orthopedic
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022380·600 micron core/1040 micron OD Luer Lock Diode ...
Zavation
FDA UDI
Zavation LLC·00197157002848·CIF 14x18, 8 deg, -08
Lumbar IBFD
FDA UDI
KEOS·B084KPS12308080·
Lumbar IBFD
FDA UDI
KEOS·B084KPS22308080·
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
FDA 510(k)
FDA Class 2
·Dental
HANSON MEDICAL CALF IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PLUM A+ PUMP MEDNET WIRELESS
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·November 6, 2008
AVAULTA PLUS SYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC.·Product code FTL·August 23, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 1, 2017
BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 3, 2023
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020