248 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code GDC·June 28, 2024
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
FDA Recall
Open, Classified
·Sonendo Inc·Product code ELC·October 14, 2022
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KTI·April 4, 2025
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 1, 2024
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·April 5, 2023
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·April 5, 2023
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·November 6, 2024
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B
FDA Recall
Open, Classified
·Intuitive Surgical, Inc.·Product code NAY·October 7, 2022
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·September 20, 2024
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·September 19, 2023
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
FDA Recall
Open, Classified
·Tecfen Medical·Product code HNN·April 25, 2025
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
FDA Recall
Open, Classified
·Tecfen Medical·Product code HNN·April 25, 2025
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
FDA Recall
Open, Classified
·Percussionaire Corporation·Product code CBK·March 28, 2023
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;
FDA Recall
Open, Classified
·Implant Direct Sybron Manufacturing LLC·Product code NHA·May 2, 2023
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
FDA Recall
Open, Classified
·Qapel Medical Inc.·Product code NRY·February 26, 2025
Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport knives are used to create precision incisions in vitrectomy procedures. Component: No
FDA Recall
Open, Classified
·Tecfen Medical·Product code HNN·April 25, 2025
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
FDA Recall
Open, Classified
·Tecfen Medical·Product code HNN·April 25, 2025
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
FDA Recall
Open, Classified
·Tecfen Medical·Product code HNN·April 25, 2025
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
FDA Recall
Open, Classified
·Volcano Corp·Product code IYO·January 24, 2022
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
FDA Recall
Open, Classified
·Sonendo Inc·Product code ELC·October 14, 2022