15 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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OSTEOGRAF/N-300
FDA 510(k)
FDA Class 2
·Dental
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540337894·DELTA PLATE FORCEPS
BRIDGE FX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 8, 2025
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503515627·TPU,Straight,7Fr,18cm working length with 1700m...
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514019·TPU,Side bend,7Fr,18cm working length with 1700...
Biliary Plastic Stent Set/ short-wire compatible
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514767·TPU,Side bend,7Fr,18cm working length with 1700...
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514255·TPU,Center bend,7Fr,18cm working length with 17...
Biliary Plastic Stent Set/ short-wire compatible
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514941·TPU,Center bend,7Fr,18cm working length with 17...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.
FDA Enforcement
Class II
·Terminated·Stryker Communications·March 7, 2018
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·April 22, 2013
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·April 28, 2011
I-CLIP PLA 10MM DISP INSTR 20 CLIPX1
FDA Adverse Event
Malfunction
·TREVOUX - USS·Product code GDO·July 8, 2008