27 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
FDA Recall
Open, Classified
·American Contract Systems, Inc.·Product code OJH·March 22, 2022
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
FDA Recall
Open, Classified
·American Contract Systems, Inc.·Product code OJG·March 22, 2022
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
FDA Recall
Open, Classified
·Hologic, Inc.·Product code OTE·January 16, 2023
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
FDA Recall
Open, Classified
·Hologic, Inc·Product code MUE·April 8, 2026
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
FDA Recall
Open, Classified
·Inari Medical Oak Canyon·Product code QEW·July 19, 2024
Artix MT Thrombectomy Device, REF: 32-102
FDA Recall
Open, Classified
·Inari Medical Oak Canyon·Product code QEW·April 8, 2025
OEC Elite Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
OEC 9900 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC 9800 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel
FDA Recall
Open, Classified
·Mac Medical Supply Co Inc·Product code ITX·August 4, 2021
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code CAC·September 18, 2023
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code CAC·November 27, 2018
Atrium Oasis Drain Single W / AC, Part No. 3600-100
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code CAC·November 1, 2023