15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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StealthStation System with Cranial Software
FDA 510(k)
FDA Class 2
·Neurology
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
STEALTHSTATION® S7
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100455·LIEBERMAN INFANT SPECULUM K-WIRE
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
FDA 510(k)
FDA Unclassified
·Unknown
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·May 29, 2019
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 7, 2011
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020