17 results · 17ms · Sources: EU EUDAMED, US FDA

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Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FDE·August 16, 2023

Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FOS·May 2, 2025

Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FOS·May 2, 2025

Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FOS·May 2, 2025

Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FOS·May 2, 2025

Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FOS·May 2, 2025

Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FOS·May 2, 2025

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