8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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W&H AIR MOTOR A25
FDA 510(k)
FDA Class 1
·Dental
BC 1220 ANALOG - IMPLANT BODY
FDA 510(k)
FDA Class 2
·Dental
MODELS 134, 135 & 136 TRANSFER CART/TABLE
FDA 510(k)
FDA Class 2
·Physical Medicine
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·February 5, 2013
OCTRODE 8 PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL -NEUROMODULATION·Product code LGW·December 15, 2010
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 18, 2014
TVT EXACT RETROPUBIC SYSTEM
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code OTN·February 7, 2024
PKG, COBRA FORCEPS, P/N 0250080317. Laparoscopic 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.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014