17 results
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18ms
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Sources: EU EUDAMED, US FDA
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