13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arisure Closed Vial Adapter
FDA 510(k)
FDA Class 2
·General Hospital
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
FABIUS MRI
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
ENDOTAK DSP
FDA Adverse Event
Injury
·HISTORICAL PUERTO RICO·Product code NVY·July 22, 2011
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·September 19, 2008
HAMMER
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
HAMMER
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·February 11, 2020
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015