13 results
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29ms
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Sources: EU EUDAMED, US FDA
DYNAMIC EXTENSOR SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
NBAC 3.0T SMS, Spine
FDA UDI
LMT Medical Systems GmbH·04260486610209·No description.
Preat
FDA UDI
Preat Corporation·00842092123461·Reverse Cutting Bur
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400860·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408470·
THD PressKit
FDA UDI
THD SPA·08033737711279·THD PressKit is a practical and completely disp...
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CROSSER RECANALIZATION CATHETER
FDA Adverse Event
Death
·BARD PERIPHERAL VASCULAR, INC.·Product code PDU·May 1, 2014
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
PLM A+ PLATINUM MODU
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·August 10, 2010
AURICAL AUD/PMM, 1081
FDA Adverse Event
Malfunction
·NATUS MEDICAL DENMARK·Product code EWO·September 23, 2020
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