Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Nova Ortho-Med with 5 device recalls and 1 510(k) clearance. The most recent is a device recall dated Aug 26, 2024: Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Numbe….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILClass II · Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position t | Device recalls |
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBIClass II · Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position t | Device recalls |
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOClass II · Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position t | Device recalls |
| Oct 7, 2019 | Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)Class II · Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A parti | Device recalls |
| Oct 1, 2016 | 4205 Journey Rolling Walker Product Usage: used to assist people in walkingClass II · Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to th | Device recalls |
| May 23, 2006 | 7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200LK061273 · IOR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
