16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOLLI 2 System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925032248·MINI-REVERSIBLE VENT TUBE .89 MM I.D. SILICONE
LCP
FDA UDI
Synthes GmbH·10886982164551·4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-R...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036035891·
Prosthesis, Mitral Valve, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Tendyne Transcatheter Mitral Valve System
Trial BiPolar Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215045470·
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 26, 2022
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDISIL SILICONE SHEETING
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Prosthesis, Mitral Valve, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Tendyne Transcatheter Mitral Valve System
Prosthesis, Mitral Valve, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Tendyne Transcatheter Mitral Valve
Trilogy®
FDA UDI
Zimmer, Inc.·00889024119291·
ALINITY C CALCIUM2
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CJY·March 5, 2026
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·September 8, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·November 10, 2014
SQ PATCH
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code DTB·July 22, 2013