18 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FEEL-JECT INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070917·MISS RELAX 140 OPEN TOE, SIZE M, NERO, GRADUATE...
POWER TILT AND RECLINE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514644·TPU,Straight,7Fr,9cm working length with 1700mm...
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513982·TPU,Side bend,7Fr,9cm working length with 1700m...
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514224·TPU,Center bend,7Fr,9cm working length with 170...
Biliary Plastic Stent Set/ short-wire compatible
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514736·TPU,Side bend,7Fr,9cm working length with 1700m...
Biliary Plastic Stent Set/ short-wire compatible
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514910·TPU,Center bend,7Fr,9cm working length with 170...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 12, 2022
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 17, 2025
TIP FOR DHS/DCS IMPACTOR (338.28)
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HWA·April 22, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 27, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·July 7, 2008
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022