12 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
FDA Recall
Open, Classified
·Wishbone Medical, Inc.·Product code KTT·January 4, 2023
Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 114.3 cm (45 in), Model Number 62000
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DXS·March 19, 2024
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
FDA Recall
Open, Classified
·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023
Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
FDA Recall
Open, Classified
·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code NKB·June 30, 2025
JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S
FDA Recall
Open, Classified
·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code OVD·March 16, 2023
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No
FDA Recall
Open, Classified
·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·February 3, 2025
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
FDA Recall
Open, Classified
·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·January 20, 2022
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
FDA Recall
Open, Classified
·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023
Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
FDA Recall
Open, Classified
·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code NKB·June 30, 2025
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
FDA Recall
Open, Classified
·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·January 20, 2022
PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis).
FDA Recall
Open, Classified
·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code NKB·March 15, 2024
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
FDA Recall
Open, Classified
·Withings 37 Bis Rue Du General Leclerc Issy les Moulineaux CEDEX France·Product code DPS·December 19, 2022