BEUDAMED
    28 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Ongoing ×

    DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·December 13, 2023

    Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

    FDA Enforcement
    Class I ·Ongoing·DJO, LLC·October 13, 2021

    DJO EMPOWR KNEE Femoral Sizer

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·May 12, 2021

    DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·June 15, 2022

    RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·December 20, 2023

    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 17, 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

    DJO EMPOWR Knee Punch Handle, REF: 801-05-040

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·November 15, 2023

    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 17, 2025

    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 17, 2025

    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·July 28, 2021

    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·July 28, 2021

    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 27, 2023

    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 27, 2023

    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 27, 2023

    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 27, 2023

    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