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

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INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1

FDA 510(k)
FDA Class 2 ·General Hospital

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780842·LEVAMED ACTIVE ANKLE SUP SLVR R VI

VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO IMPLANTABLE CLIP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CA090, DIRECT DRIVE LCA 3/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·October 11, 2016

PELVILACE TO BIOURETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 8, 2013

MALLEABLE SUCTION MEDIUM, STANDARD TIP

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code PGW·September 23, 2014

SMART CONTROL NITINOL STENT SYSTEM

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIO·June 2, 2011

CFF03, 5X100 KII FIOS ADVFIX 6/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL·Product code GCJ·September 29, 2015

5.5 EXP VERSE UNITIZED SET SCR

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

5.5 EXP VERSE SCR 6.0X45

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022