10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRIGEN ADOLESCENT TAN
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 5, 2022
SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
FDA 510(k)
FDA Class 2
·Radiology
PROLITE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEOBLUE 3
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code LBI·August 9, 2017
LIGACLIP ENDOSCOPIC ROTATING CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 8, 2013
MOGEN CIRCUMCISION CLAMP
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code HFX·May 9, 2008
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011
PKG, 5MM X 33CM INSERT, JOHANN FORCEPS, P/N 0Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. 250080763
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
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