21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KY Grosz Liquid
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009898·3.0mm x 32mm Cannulated Lag Screw
SAIPH
FDA UDI
MATORTHO LTD·05055455506145·SAIPH Femur Cemented Green Right Size 8
OsteoMed
FDA UDI
OSTEOMED LLC·00845694071260·Cannulated 3.0 x 32mm Lag Screw Sterile Qty 5
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·April 28, 2005
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019
1030489-2019-01511
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
FUSION PRE-LOADED OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·July 22, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013
1030489-2019-01423
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·September 8, 2021
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 22, 2022
HANDLE ACETABULAR PRESS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025
ACETABULAR PRESSURIZER SMALL
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025