85 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
FDA Recall
Terminated
·GE Healthcare·Product code KPR·March 29, 2007
TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWQ·May 29, 2012
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
FDA Recall
Open, Classified
·Ortho8, Inc.·Product code JOW·July 9, 2021
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
FDA Recall
Open, Classified
·Ortho8, Inc.·Product code JOW·July 9, 2021
GE Carestation 30 anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
GE 9100c NXT anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
BD Pyxis MedStation 4000 AUX, REF 306
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
BD Pyxis MedStation ES AUX, REF 324
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWQ·April 10, 2015
BD Pyxis Med ES Auxiliary (AUX), REF 343
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JXB·November 9, 2022
Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, and penis), Neonatal/Adult Transvaginal, Peripheral Vessels and Musculo-skeletal (superficial and conventional). The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. The Siemens Aux CW transducer is a non-imaging continuous wave transducer indicated for use in transthoracic/cardiac adult and pediatric applications as well as continuous wave spectral Doppler echocardiography.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code ITX·March 21, 2009
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code MXD·March 30, 2026
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·February 13, 2025
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
FDA Recall
Terminated
·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code ELC·July 8, 2016
OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.
FDA Recall
Terminated
·Biomet, Inc.·Product code LZO·February 7, 2012
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
FDA Recall
Terminated
·Steris Corporation·Product code FTD·February 23, 2010