18 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
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
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
Radiography 7300 C; Model Number: 712037;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
ProxiDiagnost N90. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
CombiDiagnost R90 Software Version R1.0 and R1.1
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·September 8, 2021
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
CombiDiagnost R90; Model Number: 709031;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
Precision CRF; Model Number: 706400;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
ProxiDiagnost N90; Model Number: 706110;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
Hintermann Series Talar Implant, Left, Size 2 REF 302112
FDA Enforcement
Class II
·Ongoing·DT MedTech, LLC·June 17, 2026