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., part of EnovisLabelled 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 DJO with 13 510(k) clearances and 11 device recalls. The most recent is a 510(k) clearance dated Sep 29, 2026: Spinalogic Bone Growth Stimulator.
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.
| Sep 29, 2026 | Spinalogic Bone Growth StimulatorK262721 · LOF | 510(k) clearances |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-14Class II · Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Device recalls |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - IClass II · Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Device recalls |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-14Class II · Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Device recalls |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-90Class II · Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Device recalls |
| Sep 25, 2025 | Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02Class II · The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave | Device recalls |
| Sep 7, 2021 | Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCClass I · Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August | Device recalls |
| Sep 7, 2021 | GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the followClass I · Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August | Device recalls |
| Nov 27, 2020 | Compex Sport Elite 3.0K201653 · NGX | 510(k) clearances |
| Jun 25, 2018 | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended toClass II · The device accessories were not labeled with appropriate latex warning. | Device recalls |
| Jun 20, 2017 | Compex Sport EliteK170918 · NGX | 510(k) clearances |
| Jun 19, 2017 | Compex Wireless USAK170903 · NGX | 510(k) clearances |
| Jun 3, 2016 | StriveK153704 · GZJ | 510(k) clearances |
| Apr 14, 2016 | Chattanooga Revolution WirelessK153696 · IPF | 510(k) clearances |
| Feb 17, 2016 | VitalStim(R) Plus Electrotherapy SystemK153224 · IPF | 510(k) clearances |
| Apr 28, 2015 | Compex Wireless USAK143551 · NGX | 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
