49 results
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20ms
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Sources: EU EUDAMED, US FDA
MERIDIAN-II AND MERDIAN-PLUS
FDA 510(k)
FDA Class 2
·Neurology
TruForm
FDA UDI
Rmo, Inc.·00885797099679·MAN MOLAR BDS PEDO ASST 100
Gensini™
FDA UDI
MEDTRONIC, INC.·00763000199203·WVN CATH 001347 10PK 8F 125CM GENSINI
Gensini™
FDA UDI
MEDTRONIC, INC.·00613994964380·WVN CATH 001347 10PK 8F 125CM GENSINI
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001347·artVeneer life upper anteriors, ITL, C2
TensCare
FDA UDI
TENSCARE LIMITED·05033435135776·The Nouri Digital Electric Breast Pump is a pow...
Diagon
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO0013470·"Off-Set, Bi-Convex, 10mm x 39mm x 18mm, Obliq...
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENHANCED POLYETHYLENE KNEE PROSTHESES
FDA 510(k)
FDA Class 2
·Orthopedic
SOCKET WRENCH FOR VEPTR NUT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXC·August 26, 2024
SOCKET WRENCH FOR VEPTR NUT
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXC·August 19, 2022
SOCKET WRENCH FOR VEPTR NUT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXC·September 28, 2022
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·September 1, 2020
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·March 6, 2013
SMARTSTITCH WITH MAGNUMWIRE SUTURE CARTRIDGE
FDA Adverse Event
Other
·ARTHROCARE CORPORATION·Product code KOG·February 18, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 19, 2008
SOCKET WRENCH FOR VEPTR NUT
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXC·March 23, 2021
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 23, 2024
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025