16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
FDA 510(k)
FDA Class 2
·Anesthesiology
Arzzt Distal Radius and Ulna System
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
FDA 510(k)
FDA Class 2
·Orthopedic
GLOBAL UNITE STD STEM SZ 6
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code MBF·May 5, 2016
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·March 1, 2024
DXTEND STAND PE CUP D38 +3MM
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code KWS·May 18, 2016
ECHOTIP PROCORE HD ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
COOK IRELAND LTD·Product code FCG·February 21, 2013
SYBRONPRO TL
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·February 9, 2011
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·July 25, 2014
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·March 1, 2024
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024