18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIBERATOR/STROLLER II SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
AcQMap
FDA UDI
ACUTUS MEDICAL, INC.·00850027837468·Adapter Cable-Long, Ablation Adapter to AcQMap
Tobii Dynavox
FDA UDI
TOBII DYNAVOX LLC·07340074601431·SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, STE...
VERISUITE 1.6, VERISUITE-PARTICLE 1.6
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES ANTERIOR CSLP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·May 8, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·October 23, 2012
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·August 4, 2010
Material DT6110, PORT ACCESS TRAY WITH HUBER NEEDLE, LINWOOD, Distributed By: Midland Medical Supply Company 4850 Old Cheney Road Lincoln, Nebraska 68516 (402) 423-8877 (800) 742-2895, PORT ACCESS TRAY WITH HUBER NEEDLE, REORDER DT6110, STERILE..., LATEX FREE FACILITATES LINE INSERTION
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code MCY·March 31, 2011
Mojo Full Face with Headgear, All Sizes
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
Phantom 2 Nasal Vented Mask
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
iQ 2 Nasal Vented Mask
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
Mojo 2 Full Face Vented Mask, All Sizes
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
Mojo 2 Full Face Non Vented Mask, All Sizes
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
Mojo Non Vented Full Face Mask with Headgear, All Sizes
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
FDA Recall
Terminated
·Helix Medical LLC·Product code EWL·October 1, 2013
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021