25 results · 32ms · Sources: EU EUDAMED, 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