13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GETINGE 700HC-E SERIES STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
G-Probe™ Short Handle Single
FDA UDI
IRIDEX CORPORATION·00813125016036·
XINIWAVE, MODEL XW-18
FDA 510(k)
FDA Class 2
·Neurology
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·May 12, 2021
NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 9, 2024
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR·Product code MAF·July 8, 2020
CROSSFIRE ECCENTRIC INSERT 10
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·June 3, 2011
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 22, 2017