15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAVIGUS PASSIVE PROBE, MODEL NP-1000
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257124604·15-20 MV FOR MEN CLSC CALF STD NAVY IV
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502624·FIXATION SCREW 22,5 MM, TITANIUM
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101420·SS Suture, 7 per sleeve
IMPACT MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WAKO LIPID CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 15, 2011
PENTAX
FDA Adverse Event
Injury
·Product code FDS·May 8, 2008
FOOTED ATTACHMENT 2.4MM LEGEND, AF02 (B-1)
FDA Adverse Event
Malfunction
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBB·January 17, 2008
6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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