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