25 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Access Intrinsic Factor Ab
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015375541·REVISION LOCKING SCREW L80.0MM D4.0MM
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015375046·REVISION LOCKING SCREW L80.0MM D4.0MM STERILE
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101209·GOLF CLUB FOREIGN BODY SPUD
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702367157·Elvarex 3/Thigh High/Closed Toe/Dotted 5 cm sil...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702782387·ELVAREX 2/KNEE HIGH/CLOSED TOE/DOTTED 2,5 CM SI...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522408000·
Healing Abutment
FDA UDI
BICON, LLC·00813110021526·4.0 x 8.0mm 0° Healing Abutment - 2.0mm Post
NA
FDA UDI
STRYKER CORPORATION·07613327053890·Collings Knife Electrode, 24.0 Fr
WILOSN-COOK BILIARY DILATION BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IO Expandable Lumbar Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·November 10, 2014
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC·Product code MHY·September 1, 2011
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013
FUSION TITAN DILATION BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·May 4, 2018
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·January 5, 2021
LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HWX·January 5, 2021
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025