25 results · 31ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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