9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE, AMBULATORY, INFUSION PUMPS
FDA 510(k)
FDA Class 2
·General Hospital
AXSOS
FDA UDI
Stryker GmbH·07613327092271·Silicone Mat
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022834·PRLS TPL 10 UPR GING-10X18 0X18X45 RT
DESTINO TWIST, STEERABLE GUIDING SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
FDA 510(k)
FDA Class 1
·General Hospital
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·February 3, 2013
AUTOSONIX ULTRA SHEARS LONG
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code LFL·December 9, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020