12 results
·
7ms
·
Sources: EU EUDAMED, US FDA
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
FDA Enforcement
Class II
·Ongoing·Swissray Medical·September 26, 2018
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
FDA Enforcement
Class II
·Ongoing·Swissray Medical·October 3, 2018
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR PLASTIC PACK, Catalog Number:SEY35OP962 6) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96A 7) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96B 8) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96C 9) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLX 10) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLY 11) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLZ
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·February 19, 2025
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
FDA Enforcement
Class II
·Ongoing·Immuno-Mycologics, Inc·May 6, 2026
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.
FDA Enforcement
Class II
·Ongoing·CP Medical Inc·March 27, 2019
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
FDA Enforcement
Class II
·Ongoing·DJO, LLC·May 20, 2026
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: no
FDA Enforcement
Class II
·Ongoing·DJO, LLC·May 20, 2026
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
FDA Enforcement
Class II
·Ongoing·DJO, LLC·May 20, 2026
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
FDA Enforcement
Class II
·Ongoing·DJO, LLC·May 20, 2026
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
FDA Enforcement
Class II
·Ongoing·DJO, LLC·December 3, 2025
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
FDA Enforcement
Class II
·Ongoing·DJO, LLC·July 24, 2019
Custodiol HTK Solution, 500ml bottle. 10 per carton.
FDA Enforcement
Class II
·Ongoing·Dr Franz Koehler Chemie Gmbh·October 2, 2024