17 results · 18ms · Sources: EU EUDAMED, US FDA

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NONINVASIVE TEMP. PACEMAKER NTP-1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136735·

PowerBar

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746164798·FIXED FUNCT POWERBAR CLASS II 15MM UNIV 2/PK

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932694·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955931598·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930492·Percutaneous Transluminal Angioplasty Balloon C...

Plateau-X Spacer System

FDA UDI
Life Spine, Inc.·00190837012045·

POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

DAVOL PAPILLITOME

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MAXCUT DIAMOND BURS (6/pk) CRS 6855-015

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D7781006855151·MAXCUT DIAMOND BURS (6/pk) Shape: Round End Tap...

MAXCUT DIAMOND BURS (6/pk) MED 855-015

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100855151·MAXCUT DIAMOND BURS (6/pk) Shape: Round End Tap...

ANIMAS VIBE

FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·June 9, 2014

SENSIA SR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·October 5, 2010

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 3, 2012

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017