20 results · 36ms · Sources: EU EUDAMED, US FDA

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T-Edge 10, T-Edge 11

FDA 510(k)
FDA Class 2 ·General Hospital

MaXcess

FDA UDI
Nuvasive, Inc.·00887517189165·MaXcess Access Blade, 80mm Center

Vitique

FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2130801·Cementation system for definitive cementation o...

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704514780·

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA

Mariner Deformity

FDA UDI
Seaspine Orthopedics Corporation·10889981298319·Iliac Tap, Cannulated, Navigated, 8.0mm

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT

FDA 510(k)
FDA Class 2 ·Immunology

TUBALGATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

I-STAT 6+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·September 28, 2021

JAGTOME SPHINCTEROTOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 23, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

NUBUVATOR BATH BLISS RECLINING BATH LIFT

FDA Adverse Event
Malfunction ·HANDICARE·Product code FSA·July 1, 2013

INTROCAN SAFETY® 3

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

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

INTROCAN SAFETY® 3

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

ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·August 31, 2017

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 2026

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

DRX Revolution Mobile X-Ray System

FDA Enforcement
Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023