20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Safco Peeso Reamers
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310222463·Safco peeso reamers, #01-06, assortment, 6/box
SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
ABG SYRINGE,1 ML LUER-LOK SYRINGE WITH NEEDLE. REGULAR PLUNGER STOPPER &TIP CAP.
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 7, 2017
BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 6, 2017
3 ML BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP. 22 G X 1 IN BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 4, 2017
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 7, 2018
BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2017
BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 7, 2017
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 26, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011
GUIDANT VASO VIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code GCJ·March 26, 2008
BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2017
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 9, 2022
BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 11, 2022
SYR ABG PRESET 1(.6) S/T 23X1 CE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 24, 2019
BD PRESET¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·January 13, 2022
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025