32 results
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12ms
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Sources: EU EUDAMED, US FDA
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPAROSCOPY CDS-LF, TRMC GENERAL ENDOSCOPY PACK, GENERAL ENDOSCOPIC PACK-LF, RVMC LAP CHOLE PACK, LAP CHOLE PACK, MH GENERAL LAPAROSCOPY, THORACIC, GB GENERAL ENDO, T & A, DM LAPAROSCOPY PACK, THORACIC ROBOT, LAVH PACK, LAPAROSCOPY, T AND A, SINUS PACK, ROBOTICS PACK-LF, GYN LAPAROSCOPY-LF, LAPAROSCOPIC PACK, GENERAL LAP PACK, ENT PACK, OPEN HEART PK A&B&C, LAPAROSCOPIC, LAP TUBAL LIGATION PACK, ROBOTICS SI, OPEN HEART CDS, LAPAROSCOPY CDS, LAP GASTRIC BY PASS, GENERAL LAPAROSCOPY PK-LF, THORACOTOMY THORACOSCOPY, T AND A COBLATOR, ROBOTICS PACK, TOTAL LAP HYSTERECTOMY CDS, LAPAROSCOPY TRAY-LF, PATEWOOD T AND A PACK, FESS PACK, AMB MSL W INJECTION, LAP CHOLE CDS, NASAL SEPTOPLASTY PACK, ENDOSCOPY PACK, AMB GYN LAPAROSCOPY, GASTRIC BYPASS CDS-LF, MHC LAP CHOLE, HHOR ENT, LAP BARIATRIC, LAPAROSCOPY PACK, MHC OPEN HEART 1 OF 2, BARIATRIC, GENERAL LAP PACK-LF, MAG LAPAROSCOPY CDS, SPRINGHILL LAP CHOLE PACK, BMHM GASTRIC BAND-BYPASS PACK, NASAL PACK, LAPAROSCOPY PACK - OSC, ALT GENERAL LAPAROSCOPY CDS, MER ROBOTIC, JAM/HRZ GENERAL LAPAROSCOPY, ARTHROSCOPY PACK, MAJOR LITHOTOMY SOMC-LF, BARI GASTRECTOMY CDS, LAP GYN PACK-LF, THORACOTOMY PACK-LF, T&A PACK-LF, PELVISCOPY PACK, GENERAL LAPAROSCOPY-LF, ROBOT GYN, MAJOR ENT PACK, TONSIL & ADENOIDS PACK, PROSTATE ROBOTIC, CARDIAC SURGERY CABG PACK-LF, LAP CHOLE TRAY, THORASCOPIC TETHERING OR PACK, ROBOTIC PACK, LAVH, OPEN HEART, LAP CHOLE QVH VER. B, BARIATRIC-LF, T&A TRAY #64-RF, BASIC LAP PACK W TUBING, TONSIL & ADENOID PACK, CUSTOM ENDOSCOPY PACK-LF, FESS TRAY #60-RF, LAP PACK WITHOUT TUBING, NASAL SINUS ENDOSCOPY, DAVINCI, TV LAP PACK-LF, MAD T & A, ROBOTIC GU/GYN, RICH LAVH, GYN ROBOTIC-LF, MAD GYN LAPAROSCOPY, PAD GYN LAPAROSCOPY, OSC GYN LAP, SUB GYN LAPAROSCOPY PACK-LF, LAPAROSCOPY-ROBOT, GYN LAP KIT, GENERAL LAP, LAP CHOLE PACK B10, LAP CHOLE CDS-LF, GYN LAPAROSCOPY PACK-LF, LAP CHOLE SURGICOUNT, DIAGNOSTIC LAP PACK, CABG-VEIN HARVESTING PACK-LF, TONSIL PACK UOPSC-LF, BELLEVUE T&A PACK, BGH 001471 SHOULDER PACK-LF, SCOPE LAP THOR PACK, MAIN/LAPAROSCOPY GYN PACK-LF, LAP CHOLE OR PACK, ENSEMBLE THORACO-LF, LAPAROSCOPIE CHIRURGICALE-LF, MAJOR GYN LAPAROSCOPY CDS, HEPATOBILIAIRE LAPAROSCOPIE-LF, GYNE MAJOR LAPAROSCOPY GRH-LF, LAP CHOLE PACK TBRHSC-LF, MAJOR LAPAROSCOPIC SJHC-LF, LAPAROSCOPY RVHS-LF, LAPAROSCOPY III-LF.
FDA Recall
Open, Classified
·Medline Industries, Inc.·Product code OCT·May 30, 2019
PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
FDA Recall
Open, Classified
·AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada·Product code FXX·December 21, 2023
HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
FDA Recall
Open, Classified
·AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada·Product code FXX·December 21, 2023
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
FDA Recall
Open, Classified
·Owens & Minor Distribution, Inc.·Product code FXX·January 3, 2023
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
FDA Recall
Open, Classified
·Intuitive Surgical, Inc.·Product code NAY·May 17, 2018
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Covidien·Product code CCW·August 10, 2023
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Covidien·Product code CCW·August 10, 2023
BostonSight SCLERAL Lens
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
BostonSight PROSE Lens.
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FCG·March 31, 2023
Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code FEG·December 20, 2023
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
FDA Recall
Open, Classified
·Covidien Llc·Product code FCG·June 26, 2020
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
FDA Recall
Open, Classified
·Covidien Llc·Product code FCG·June 26, 2020
Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 16Fr., 48in Long , REF EN0056160
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code FEG·December 20, 2023
Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 14Fr., 48in Long, REF EN0056140
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code FEG·December 20, 2023
Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code FEG·December 20, 2023
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438·Product code FCG·August 2, 2024
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FCG·March 31, 2023
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FEG·September 18, 2025
MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FCG·May 25, 2022