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

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MediExpand Cervical Expandable VBR System

FDA 510(k)
FDA Class 2 ·Orthopedic

LuxaCore® Automix Dual

FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2121260·Core build-up composite. Core buildups and post...

NA

FDA UDI
Synthes GmbH·10886982152008·3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...

Tissue Holder

FDA UDI
KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC

Posterior Pelvic Wall Plate, Left

FDA UDI
I.T.S. GmbH·09120047302248·Posterior Pelvic Wall Plate, Left, 6-Hole, PRS ...

GENUINE FIRST AID CPR MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

THE SALICEPT ORAL PATCH

FDA 510(k)
FDA Unclassified ·Unknown

BD LUER-LOK

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 16, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 29, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

PRIME ZOOM STRETCHER, ELECTRIC

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·July 8, 2013

FLEXOR SHUTTLE GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·August 2, 2016

FLEXOR SHUTTLE GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·August 2, 2016

FLEXOR SHUTTLE GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·August 5, 2016

Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

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

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021