49 results
·
8ms
·
Sources: EU EUDAMED, US FDA
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·September 3, 2025
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
FDA Enforcement
Class II
·Ongoing·Oakworks Inc·January 24, 2024
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 10, 2026
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 10, 2026
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025