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

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Diagnostic X-ray System/PLX5200A

FDA 510(k)
FDA Class 2 ·Radiology

Securi-T

FDA UDI
HOLLISTER INCORPORATED·00610075069583·2-Pc Ostomy System

GII QUICKANCHOR PANACRYL

FDA UDI
DEPUY MITEK, LLC·10886705001989·GII QUICKANCHOR Plus Size 2 (5 metric) PANACRYL...

NA

FDA UDI
Synthes GmbH·10886982152060·3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·February 8, 2002

GC E-LIGHT

FDA 510(k)
FDA Class 2 ·Dental

TRUCLEAR OPERATIVE HYSTEROSCOPE

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

DEPUY ASR XL FEM IMP SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 29, 2014

4 MOTOR ADVANCE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·July 8, 2011

COULTER® LH 750 ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·July 9, 2013

MITEK NON ABSORBABLE ANCHOR IMPLANT

FDA Adverse Event
Injury ·DEPUY MITEK·Product code JDR·January 25, 2013

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025