20 results
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23ms
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Sources: EU EUDAMED, US FDA
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
FDA Recall
Open, Classified
·Wilson-Cook Medical Inc.·Product code QAU·October 31, 2024
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
FDA Recall
Open, Classified
·Wilson-Cook Medical Inc.·Product code QAU·May 22, 2023
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
FDA Recall
Open, Classified
·Hologic, Inc·Product code NEU·March 13, 2024
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
FDA Recall
Open, Classified
·Stryker Corporation·Product code NEU·January 21, 2026
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
FDA Recall
Open, Classified
·Hologic, Inc·Product code NEU·August 9, 2022
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
FDA Recall
Open, Classified
·Devicor Medical Products Inc·Product code NEU·April 24, 2026
BioZorb Marker. Radiographic soft tissue marker.
FDA Recall
Open, Classified
·Hologic, Inc·Product code NEU·October 10, 2024
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
FDA Recall
Open, Classified
·Healthmark Industries Co., Inc.·Product code OCU·March 12, 2026
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
FDA Recall
Open, Classified
·ENDOMAGNETICS LTD St. Johns Innovation Park Cowley Road Cambridge United Kingdom·Product code NEU·October 1, 2025
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
FDA Recall
Open, Classified
·ENDOMAGNETICS LTD St. Johns Innovation Park Cowley Road Cambridge United Kingdom·Product code NEU·October 1, 2025
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.
FDA Recall
Open, Classified
·Elucent Medical Inc·Product code NEU·November 18, 2024
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
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