BEUDAMED
    15 results · 17ms · Sources: EU EUDAMED, US FDA

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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 Recall
    Open, Classified ·Kico Knee Innovation Company·Product code SBF·September 19, 2025

    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 Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    FIRST RESPONSE 2 CT, SKU 902343

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code LCX·October 4, 2023

    FIRST RESPONSE 2 CT, SKU 902343

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code LCX·June 23, 2022

    VERIQUICK PREGNANCY TEST 1CT, SKU 901260

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code LCX·October 4, 2023

    Veriquick Pregnancy Test 2CT, SKU 903756

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code LCX·June 23, 2022

    VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code LCX·June 23, 2022

    CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code LCX·October 4, 2023

    CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code LCX·June 23, 2022

    TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code EFW·June 23, 2022

    Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·August 13, 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 Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFG·February 11, 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 Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OXQ·April 8, 2024

    iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453 85454 85455 Product Code/UDI /Description: 85400 00650862854008 iCAST COVERED STENT,5MMX38MMX80CM 85401 00650862854015 iCAST COVERED STENT,5MMX59MMX80CM 85402 00650862854022 iCAST COVERED STENT,6MMX38MMX80CM 85403 00650862854039 iCAST COVERED STENT,6MMX59MMX80CM 85404 00650862854046 iCAST COVERED STENT,7MMX38MMX80CM 85405 00650862854053 iCAST COVERED STENT,7MMX59MMX80CM 85406 00650862854060 iCAST COVERED STENT,8MMX38MMX80CM 85407 00650862854077 iCAST COVERED STENT,8MMX59MMX80CM 85408 00650862854084 iCAST COVERED STENT,9MMX38MMX80CM 85409 00650862854091 iCAST COVERED STENT,9MMX59MMX80CM 85410 00650862854107 iCAST COVERED STENT,5MMX38MMX120CM 85411 00650862854114 iCAST COVERED STENT,5MMX59MMX120CM 85412 iCAST COVERED STENT,6MMX38MMX120CM 85413 00650862854138 iCAST COVERED STENT,6MMX59MMX120CM 85414 00650862854145 iCAST COVERED STENT,7MMX38MMX120CM 85415 00650862854152 iCAST COVERED STENT,7MMX59MMX120CM 85416 00650862854169 iCAST COVERED STENT,8MMX38MMX120CM 85417 00650862854176 iCAST COVERED STENT,8MMX59MMX120CM 85418 00650862854183 iCAST COVERED STENT,9MMX38MMX120CM 85419 00650862854190 iCAST COVERED STENT,9MMX59MMX120CM 85420 00650862854206 iCAST COVERED STENT,10MMX38MMX80CM 85424 00650862854244 iCAST COVERED STENT,10MMX38MMX120CM 85440 00650862854404 iCAST COVERED STENT,5MMX16MMX80CM 85441 00650862854411 iCAST COVERED STENT,5MMX22MMX80CM 85442 00650862854428 iCAST COVERED STENT 6MMX16MMX80CM 85443 00650862854435 iCAST COVERED STENT,6MMX22MMX80CM 85444 00650862854442 iCAST COVERED STENT,7MMX16MMX80CM 85445 00650862854459 iCAST COVERED STENT,7MMX22MMX80CM 85450 00650862854503 iCAST COVERED STENT,5MMX16MMX120CM 85451 00650862854510 iCAST COVERED STENT,5MMX22MMX120CM 85452 00650862854527 iCAST COVERED STENT,6MMX16MMX120CM 85453 00650862854534 iCAST COVERED STENT,6MMX22MMX120CM 85454 00650862854541 iCAST COVERED STENT,7MMX16MMX120CM 85455 00650862854558 iCAST COVERED STENT,7MMX22MMX120CM

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code JCT·March 3, 2022

    Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388 85389 85390 85391 85392 85394 85395 85396 85397 85398 85370 85371 85372 and 85379. Product Code/UDI /Description: 85320 650862853209 Advanta V12 Covered Stent, 5mm x 38mm x 80cm; 85321 650862853216 Advanta V12 Covered Stent, 5mm x 59mm x 80cm; 85322 650862853223 Advanta V12 Covered Stent, 6mm x 38mm x 80cm; 85323 650862853230 Advanta V12 Covered Stent, 6mm x 59mm x 80cm 85324 650862853247 Advanta V12 Covered Stent, 7mm x 38mm x 80cm; 85325 650862853254 Advanta V12 Covered Stent, 7mm x 59mm x 80cm; 85326 650862853261 Advanta V12 Covered Stent, 8mm x 38mm x 80cm; 85327 650862853278 Advanta V12 Covered Stent, 8mm x 59mm x 80cm; 85328 650862853285 Advanta V12 Covered Stent, 9mm x 38mm x 80cm; 85329 650862853292 Advanta V12 Covered Stent, 9mm x 59mm x 80cm; 85330 650862853308 Advanta V12 Covered Stent, 5mm x 38mm x120cm; 85331 650862853315 Advanta V12 Covered Stent, 5mm x 59mm x120cm; 85332 650862853322 Advanta V12 Covered Stent, 6mm x 38mm x120cm; 85333 650862853339 Advanta V12 Covered Stent, 6mm x 59mm x120cm; 85334 650862853346 Advanta V12 Covered Stent, 7mm x 38mm x120cm; 85335 650862853353 Advanta V12 Covered Stent, 7mm x 59mm x120cm; 85336 650862853360 Advanta V12 Covered Stent, 8mm x 38mm x120cm; 85337 650862853377 Advanta V12 Covered Stent, 8mm x 59mm x120cm; 85338 650862853384 Advanta V12 Covered Stent, 9mm x 38mm x120cm; 85339 650862853391 Advanta V12 Covered Stent, 9mm x 59mm x120cm; 85340 650862853407 Advanta V12 Covered Stent, 5mm x 16mm x 80cm; 85341 650862853414 Advanta V12 Covered Stent, 5mm x 22mm x 80cm; 85342 650862853421 Advanta V12 Covered Stent, 6mm x 16mm x 80cm; 85343 650862853438 Advanta V12 Covered Stent, 6mm x 22mm x 80cm; 85344 650862853445 Advanta V12 Covered Stent, 7mm x 16mm x 80cm; 85345 650862853452 Advanta V12 Covered Stent, 7mm x 22mm x 80cm; 85350 650862853506 Advanta V12 Covered Stent, 5mm x 16mm x 120cm; 85351 650862853513 Advanta V12 Covered Stent, 5mm x 22mm x 120cm; 85352 650862853520 Advanta V12 Covered Stent, 6mm x 16mm x 120cm; 85353 650862853537 Advanta V12 Covered Stent, 6mm x 22mm x 120cm; 85354 650862853544 Advanta V12 Covered Stent, 7mm x 16mm x 120cm; 85355 650862853551 Advanta V12 Covered Stent, 7mm x 22mm x 120cm; 85360 650862853605 Advanta V12 Covered Stent, 10mm x 38mm x 80cm; 85361 650862853612 Advanta V12 Covered Stent, 10mm x 59mm x 80cm; 85364 650862853643 Advanta V12 Covered Stent, 10mm x 38mm x 120cm; 85365 650862853650 Advanta V12 Covered Stent, 10mm x 59mm x 120cm; 85370 650862853704 Advanta V12 Large Diameter, 12mm x 29mm x 80cm; 85371 650862853711 Advanta V12 Large Diameter, 12mm x 41mm x 80cm; 85372 650862853728 Advanta V12 Large Diameter, 12mm x 61mm x 80cm; 85379 650862853797 Advanta V12 Large Diameter, 12mm x 29mm x 120cm; 85388 650862853889 Advanta V12 Covered Stent, 5mm x 32mm x 80cm; ;85390 650862853902 Advanta V12 Covered Stent, 7mm x 32mm x 80cm; 85391 650862853919 Advanta V12 Covered Stent, 8mm x 32mm x 80cm; 85392 650862853926 Advanta V12 Covered Stent, 9mm x 32mm x 80cm; 85394 650862853940 Advanta V12 Covered Stent, 5mm x 32mm x 120cm; 85395 650862853957 Advanta V12 Covered Stent, 6mm x 32mm x 120cm. 85396 650862853964 Advanta V12 Covered Stent, 7mm x 32mm x 120cm 85397 650862853971 Advanta V12 Covered Stent, 8mm x 32mm x 120cm 85398 650862853988 Advanta V12 Covered Stent, 9mm x 32mm x 120cm

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code JCT·March 3, 2022