28 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EPIEN Dental Cleanser
FDA 510(k)
FDA Unclassified
·Unknown
HHM
FDA UDI
Oticon A/S·05707131355171·G300 SC, MINIRITE 312 2.4G C094 HHM
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136024929·7450 XS FACE MASK-HDGR 22mmOD
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50
Stratum Reduced Size Foot Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
SURGISIS PERIPHERAL VASCULAR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
2520274-2013-06518
FDA Adverse Event
Injury
·SYNTHES, USA·Product code HWC·September 25, 2013
2520274-2013-06522
FDA Adverse Event
Injury
·SYNTHES, USA·Product code HRS·September 25, 2013
2530088-2013-01203
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·September 30, 2013
2520274-2013-06607
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·September 30, 2013
QUARTET LEAD DOUBLE BEND, 86 CM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code OJX·September 15, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code MEA·July 20, 2023
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·December 21, 2021
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008
ACTIVA PC
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 5, 2011
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·July 2, 2013
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
SYNERGY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·March 18, 2022
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·October 13, 2017