25 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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MANI NEEDLE & SUTURE PACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911050150·TRACHEA TUBE, AIR-LON - SIZE 3
Sportex
FDA UDI
Diversified Products, Inc.·00037741405023·
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934186·Percutaneous Transluminal Angioplasty Balloon C...
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376633466·PSIS Pin, 150mm
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932960·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933578·Percutaneous Transluminal Angioplasty Balloon C...
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376688640·PSIS PIN, STERILE 150mm
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
FDA 510(k)
FDA Class 2
·Neurology
CRC-15BT
FDA 510(k)
FDA Class 2
·Radiology
Widex
FDA UDI
Widex A/S·05706069897760·WIDEX EVOKE E-XP (Light beige ) 100, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069897777·WIDEX EVOKE E-XP (Clay brown ) 100, Telecoil, R...
Widex
FDA UDI
Widex A/S·05706069897784·WIDEX EVOKE E-XP (Dark brown ) 100, Telecoil, R...
PROGRASP (TM) FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 12, 2012
PRECISE BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 7, 2013
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 10, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 1, 2011
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·May 19, 2008
2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2023