59 results
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20ms
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Sources: EU EUDAMED, US FDA
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
FDA Recall
Open, Classified
·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
FDA Recall
Open, Classified
·Luminex Corporation·Product code OCC·October 30, 2020
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAE·October 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAE·October 10, 2024
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
FDA Recall
Open, Classified
·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
FDA Recall
Open, Classified
·Abbott·Product code OAE·September 10, 2025
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAE·October 10, 2024
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
FDA Recall
Open, Classified
·Luminex Corporation·Product code OCC·December 10, 2018
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
FDA Recall
Open, Classified
·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
FDA Recall
Open, Classified
·Abbott·Product code OAE·March 24, 2022
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
FDA Recall
Open, Classified
·Hologic, Inc·Product code OCC·October 10, 2019
Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
FDA Recall
Open, Classified
·Luminex Corporation·Product code OCC·October 30, 2020
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
FDA Recall
Open, Classified
·Luminex Corporation·Product code OCC·October 30, 2020
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
FDA Recall
Open, Classified
·Luminex Corporation·Product code OCC·October 30, 2020
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
FDA Recall
Open, Classified
·Abbott·Product code OAE·March 24, 2022
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
FDA Recall
Open, Classified
·Abbott·Product code OAE·September 10, 2025
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
FDA Recall
Open, Classified
·Luminex Corporation·Product code OCC·October 30, 2020