22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUJIFILM Double Balloon Endoscope EI580BT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270534·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528128251·3.0 X 32mm Cannulated Headed Screw, T10
8.3MHz PENCIL PROBE 7' SHLD
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787021028·
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
PERI-LOC BONE PLATING AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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 17, 2014
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code DHA·June 21, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 28, 2011
1030489-2019-01423
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019
VNGD CR TIB BRG 10X79/83
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 13, 2022
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·August 13, 2021
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
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 27, 2022