13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
STIMUPLEX-DIG-RC NERVE STIMULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
2040 Ceramic Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005411·COSMETIC 20/40 LR 1ST BIC 022 T-17 A=0 R=0
MIRAGE S.r.l.
FDA registration
MIRAGE S.r.l.·4 products·🇮🇹 Italy
740 SELECT
FDA UDI
ZOE MEDICAL INCORPORATED·00851920007408·The 740 SELECT Monitor is intended for monitori...
EN SNARE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code MMX·September 8, 2011
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AGILITY STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
PARACENTESIS KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code KDD·March 20, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·March 16, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·March 26, 2008
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014