99 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Cardiovascular
METAPHYSARY BROACH ESOP LEFT SIZE 15
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489017605·
HHM
FDA UDI
Oticon A/S·05707131351869·G300 SC, BTE PP 13 2.4G 105 C044 TAR HHM
NA
FDA UDI
Synthes GmbH·10886982142719·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750007486·2700B SUBASSY w/INH 35mmID ORG
CODMAN
FDA UDI
Cerenovus, Inc.·10886704002017·CODMAN SLIM-LINE Aneurysm Clip Graft 2mm Diamet...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111027277·NEIVERT NH 5" 1 OFFSET RING
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDS·May 19, 2023
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856044630·Ti ILIAC BONE SCREW ASSY, 8.5mm X 60mm X 30°
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856044623·TI ILIAC BONE SCREW ASSY, 8.5MM X 60MM X 15°
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2017600·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...
RADIOLUCENT COLLES FRACTURE KIT
FDA 510(k)
FDA Class 2
·Orthopedic
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
FDA 510(k)
FDA Class 2
·Neurology
RAD-G
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 2, 2012
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·October 14, 2008
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 5, 2011
LTV
FDA Adverse Event
Death
·CAREFUSION 203, INC·Product code CBK·July 2, 2013
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Stryker Spine·November 27, 2013