13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.
FDA Enforcement
Class II
·Ongoing·Kico Knee Innovation Company·October 22, 2025
FIRST RESPONSE 2 CT, SKU 902343
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·November 15, 2023
VERIQUICK PREGNANCY TEST 1CT, SKU 901260
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·November 15, 2023
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·November 15, 2023
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
FIRST RESPONSE 2 CT, SKU 902343
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
Veriquick Pregnancy Test 2CT, SKU 903756
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025
Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1159B; 6) SUTURE TRAY, Pack Number DYNDS1064B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024