60 results
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14ms
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Sources: EU EUDAMED, US FDA
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Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·November 30, 2020
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
FDA Recall
Open, Classified
·Nihon Kohden America Inc·Product code GWQ·December 21, 2020
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
FDA Recall
Open, Classified
·W & H DENTALWERK BUERMOOS GMBH Ignaz Glaser Strase 53 53 IGNAZ-GLASER-STRASSE BUERMOOS Austria·Product code KMW·January 16, 2024
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code HXK·May 18, 2023
BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MJA·May 20, 2025
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code NKB·July 15, 2022
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code FSM·February 23, 2023
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. Product Code: 332079
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code OGE·January 22, 2024
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code GEI·March 21, 2023
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathecal anesthesia. Product Code: 332248
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code OGE·January 22, 2024
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FPA·August 8, 2024
Aeos Robotic Digital Microscope, Product Code: PV010
FDA Recall
Open, Classified
·Aesculap Inc·Product code FSO·May 13, 2024
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FMF·August 7, 2023
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FMF·August 7, 2023
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DXQ·October 28, 2025
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
FDA Recall
Open, Classified
·Ethicon Sarl, a Johnson & Johnson Company rue du Puits-Godet 20 Neuchatel Switzerland·Product code LMG·June 11, 2024
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MJA·July 18, 2024
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
FDA Recall
Open, Classified
·Bausch & Lomb Surgical, Inc.·Product code HQL·March 27, 2025
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
FDA Recall
Open, Classified
·Bausch & Lomb Surgical, Inc.·Product code MFK·March 27, 2025
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
FDA Recall
Open, Classified
·Product code FMF·April 28, 2026