9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
FDA 510(k)
FDA Class 2
·General Hospital
Brisbane ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215018368·
QLAB QUANTIFICATION SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
VINTAGE AL
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·November 14, 2008
SYNCHRON® CX9 ALX CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 2, 2011
LINOX SMART S DX 65/17
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 17, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014