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

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ClotTriever Thrombectomy System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Bernafon

FDA UDI
Bernafon AG·05711584114933·CZ7 MNR, 2.4G NFM MSIL/MAC CORAL 7 GPL

TOURNIQUET CUFF; PNEUMATIC TOURNIQUET

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

GUAVA II

FDA 510(k)
FDA Class 2 ·Cardiovascular

PFC SIG RPF CEM FEM SZ 5 LT

FDA Adverse Event
Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 24, 2008

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 11, 2011

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

FDA Enforcement
Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 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

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

DRX Revolution Mobile X-Ray System

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