14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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