25 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Inbrace Orthodontic System
FDA 510(k)
FDA Class 2
·Dental
16PW - Washington Gas - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014425·16PW - Washington Gas - Poly White
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450192429·
MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·January 19, 2024
EXTRA LARGE BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO EDI VERIS SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2022
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 18, 2025
PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 8, 2023
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·July 16, 2025
MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·February 16, 2022
MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code NKB·March 29, 2023
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·October 15, 2008
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 2, 2013
MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·July 7, 2021
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025