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

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Lorals

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

LVIS

FDA UDI
Microvention, Inc.·00816777026019·Stent

LVIS

FDA UDI
Microvention, Inc.·00842429100929·Stent

RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME

FDA 510(k)
FDA Class 1 ·General Hospital

ABI VEST AIRWAY CLEARANCE SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

LC4200 PCA PLUS AUST

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012

LC4200 PCA AUST

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code MEA·October 20, 2010

PCA PUMP (AUZ)

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012

LC4200 PCA PLUS AUST

FDA Adverse Event
Injury ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012

PCA PUMP (AUZ)

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code MEA·June 2, 2010

ALARIS SE PUMP

FDA Adverse Event
Injury ·CAREFUSION CORPORATION·Product code FRN·August 3, 2011

STELLANT CT SYRINGE KIT

FDA Adverse Event
Malfunction ·BAYER MEDICAL CARE, INC.·Product code DXT·August 4, 2014

VITALITY 2

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

Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·July 24, 2019

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