17 results
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19ms
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Sources: EU EUDAMED, US FDA
ViewFinder Software Version 1.1
FDA 510(k)
FDA Class 2
·Radiology
ZESPIN SI Joint Fusion System
FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551077535·Elevator, 1.5 mm, 16 cm
Universal Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235018·
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540356703·MEASURING SLEEVE FOR 2.0/2.3MM TAPS
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776322885·Sinus Curette
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2019
Portex
FDA UDI
ICU MEDICAL, INC.·15019517110227·
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
GOLD CORE 35
FDA 510(k)
FDA Class 2
·Dental
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 25, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 12, 2013
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023