15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PriMatrix Dermal Repair Scaffold
FDA 510(k)
FDA Unclassified
·Unknown
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100608·KATENA DOUBLE-X SPECULUM K-WIRE SMALL
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100349·FEMTO SPECULUM FLAT WIRE
CAPNOSTREAM20P WITH HIFI C02 MONITORING
FDA 510(k)
FDA Class 2
·Anesthesiology
GE LOGIQ I, LOGIQ E AND VIVID E
FDA 510(k)
FDA Class 2
·Radiology
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
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 8, 2013
LIGAMAX-5MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 7, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020