77 results
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33ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL TRAY (560523), SSK ORLANDO REGIONAL MED CENTER (560533), SSK BON SECOURS HEALTH SYS 20115122 (560538), SSK MANATEE MEMORIAL (560572), SSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580), SSK SHANDS TEACHING HOSP. & CLINICS, INC (560584), SSK UNIVERSITY OF COLORADO (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK MAYO CLINIC - BUPIVACAINE TRAY (560609), SSK THE MEDICAL CENTER (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK MAYO CLINIC OB DEPT - SPINAL (560645), SSK BAPTIST HOSPITAL OF MIAMI (560646), SSK MERCY GILBERT MEDICAL CENTER (560647), SSK ST.MARY'S HOSPITAL (560648), SSK HARRIS HEALTH SYSTEM (560660), OHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667), ALBANY MEDICAL CENTER, SSK (560670), STONY BROOK HOSPITAL - SPINAL TRAY SSK (560672);
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code OFU·May 6, 2026
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code QJR·December 15, 2022
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
FDA Recall
Open, Classified
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWQ·January 15, 2021