11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
t:slim X2 insulin pump with interoperable technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035658·Reamers With Silicone Stops 25MM #25
Showerbed
FDA UDI
Ropox A/S·05707581000485·
Next Science Wound Gel
FDA 510(k)
FDA Unclassified
·Unknown
LANDLEX, MODEL S300X
FDA 510(k)
FDA Class 2
·Physical Medicine
PMF, THREADED WIRES D 2.0 MM LENGTH 100/15 MM
FDA Adverse Event
Malfunction
·ORTHOFIX SRL·Product code LRN·December 2, 2008
ACCU-CHEK INFORM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORPORATION·Product code NBW·September 6, 2011
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·July 29, 2013
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·September 3, 2025
Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·September 19, 2018
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013