13 results
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19ms
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Sources: EU EUDAMED, US FDA
SonarMed AirWave, Airway Monitoring System
FDA 510(k)
FDA Class 2
·Anesthesiology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052016227·Full Radius Resector 4,2-15°gebogen
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1430220·Rod Cutter, Table Top
CADD
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·November 23, 2021
ATMOS E 201 THORAX AND ATMOS S 201 THORAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
FDA 510(k)
FDA Class 2
·Dental
SENOMARK BREAST BIOPSY MARKER
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code NEU·May 23, 2013
PARASIGM REAL TIME REVEL INSULIN INFUISON PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 27, 2014
HILL-ROM NURSE CALL DATABASE SERVERS
FDA Adverse Event
Malfunction
·HILL-ROM·Product code ILQ·June 14, 2011
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15
FDA Enforcement
Class II
·Terminated·Hospira Inc.·August 24, 2016