16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HRK-63 KNEE ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
Safco Incite Slow Speed Handpiece Set
FDA UDI
SAFCO DENTAL SUPPLY CO.·00810063750534·Safco Incite low speed motor set
CONVAID PRODUCTS LLC
FDA registration
CONVAID PRODUCTS LLC·4 products·🇺🇸 United States
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
FDA 510(k)
FDA Class 3
·Orthopedic
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 8, 2014
BD SMARTSITE¿ NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·October 13, 2022
BD SMARTSITE¿ NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·October 13, 2022
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 27, 2013
COULTER LH500
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·March 18, 2011
BALLOON APPLICATOR KIT - 4-5 SPHERICAL
FDA Adverse Event
Malfunction
·XOFT, INC.·Product code JAQ·March 28, 2008
M2A-MAGNUM 42-50MM TPR INSRT-3
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 4, 2018
M2A-MAGNUM MOD HD SZ 42MM 42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 4, 2018
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018