12 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
FDA 510(k)
FDA Class 1
·Dental
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
FDA 510(k)
FDA Class 2
·Radiology
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE BD CHROMAGAR O-157 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·August 10, 2021
PLATE BD CHROMAGAR O-157 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·August 10, 2021
ISODUR PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 8, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 22, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 8, 2008
DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM-STERILE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·April 27, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018