12 results
·
29ms
·
Sources: EU EUDAMED, US FDA
INTELLISAVE AX700 ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Clement Clarke International
FDA UDI
CLEMENT CLARKE INTERNATIONAL LIMITED·05023323029461·ONE WAY VALVE INSPIRATORY (200)
ArgenZ HT+ 98x20 C1
FDA UDI
ARGEN CORPORATION, THE·D818122063·Dental porcelain/ceramic restoration kit
Class B 21 Retrofit - ZLB
FDA UDI
Certified Safety Manufacturing, Inc.·00766588220635·Class B 21 Retrofit - ZLB
SAFEPRO SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
HEALTH-E-CONNECT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 21, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·May 24, 2011
ADVIA CENTAUR
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS INC.·Product code JJE·August 14, 2008
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020