13 results · 14ms · Sources: EU EUDAMED, US FDA

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Pink Luminous Breast, Breast transilluminator

FDA Recall
Open, Classified ·Silkprousa LLC·Product code LEK·May 20, 2024

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·August 11, 2025

Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021

Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·January 27, 2023

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021

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

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

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