46 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRIMAL OK INTERSPINOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Bur PM2-70 80K steel Ø1.4mm sterile
FDA UDI
Bien-Air Surgery SA·J00711003540011·
Bur PM2-70 80K Steel Ø1.4 St
FDA UDI
Bien-Air Surgery SA·17630055503203·
Thermo Scientific Pacific Hemostasis®
FDA UDI
Fisher Diagnostics·00845275000535·
DYNAMIC AXIAL FIXATOR
FDA UDI
ORTHOFIX SRL·18053504364764·Component. Not for sale. Used for reporting Dir...
Mariner MIS
FDA UDI
Seaspine Orthopedics Corporation·10889981212537·Extended Tab Body CT
STAINLESS STEEL COAXIAL ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707089009·.0175 Lower Stainless Steel Pro Form™ Coaxial A...
5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 26, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 2, 2015
IMPLANT, FIXATION DEVICE CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDP·February 23, 2017
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981056285·Plate - 3 Level - 54 mm
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
FDA 510(k)
FDA Class 2
·Physical Medicine
FIXCET SPINAL FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JDP·June 1, 2015
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 18, 2014
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·May 13, 2011
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·October 16, 2025
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·October 16, 2025