587 results
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7ms
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Sources: EU EUDAMED, US FDA
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 22, 2022
Model No. CYF-5, Cystonephrofiberscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-5R, Cystonephrofiberscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.
FDA Enforcement
Class II
·Ongoing·SunMed Holdings, LLC·November 29, 2023
Visera Hysterovideoscope Olympus HYF Type V
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·September 6, 2023
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·March 4, 2026
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 29, 2026