24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FREELITE KAPPA FREE KIT
FDA 510(k)
FDA Class 2
·Immunology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776409319·Smith Sagittal Split Separator Curved Right 9mm
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036008031·
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0104010·Caddie Lid, Trials
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100410·Caddie Lid, Curved Rods
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0104010·Caddie Lid, Cages, Universal
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BODYGUARD
FDA 510(k)
FDA Class 2
·General Hospital
OMNILINK ELITE PERIPHERAL STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIO·January 31, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·March 19, 2013
THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-LX-TE4BE1EB
FDA Adverse Event
Death
·ST. JUDE MEDICAL, IRVINE·Product code OAD·March 1, 2011
RADIESSE
FDA Adverse Event
Malfunction
·BIOFORM MEDICAL·Product code LYC·February 5, 2008
FENTANYL
FDA Adverse Event
Injury
·Product code QIX·August 1, 2025
FENTANYL
FDA Adverse Event
Injury
·Product code QIX·August 8, 2025
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 8, 2013
FENTANYL
FDA Adverse Event
Malfunction
·Product code QIX·September 2, 2025
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 25, 2026
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 3, 2019
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
FDA Enforcement
Class II
·Terminated·GE Healthcare·June 13, 2018