84 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INOMAX DS
FDA 510(k)
FDA Class 2
·Anesthesiology
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
FDA Enforcement
Class II
·Terminated·Interventional Spine Inc·January 11, 2017
PMMA disc
FDA UDI
Dentsply International Inc.·D00180715160·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293579·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771014584·SteSteinmann Pins, Single trocar, round end, 7/...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049743·SteSteinmann Pins, Single trocar, round end, 7/...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484962·Steinmann pin w. trocar/round end _x000D_...
Steinmann pin w. trocar/round end 2.8mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM715160·Steinmann pin w. trocar/round end
2.8mm/...
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453047·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453054·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453061·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453108·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453085·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453078·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453115·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453092·
INFANT FLOW SYSTEM, MODEL M672P
FDA 510(k)
FDA Class 2
·Anesthesiology
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 6, 2020
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 22, 2013