587 results · 7ms · Sources: EU EUDAMED, US FDA

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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