207 results
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21ms
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Sources: EU EUDAMED, US FDA
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.
FDA Recall
Open, Classified
·IMRIS Imaging Inc·Product code HBL·December 8, 2025
DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Recall
Open, Classified
·Pro-Med Instruments Gmbh BOETZINGER STRASSE 86 Freiburg Im Breisgau Germany·Product code HBL·March 14, 2025
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Recall
Open, Classified
·Bio-Rad Laboratories·Product code OYX·February 15, 2024
Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Recall
Open, Classified
·Cepheid·Product code OYX·October 30, 2025
Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Recall
Open, Classified
·Cepheid·Product code OYX·October 30, 2025
Omnipod 5 Automated Insulin Delivery System
FDA Recall
Open, Classified
·Product code QFG·February 28, 2023
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
FDA Recall
Open, Classified
·NuVasive Inc·Product code OLO·July 19, 2022
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
FDA Recall
Open, Classified
·Davol, Inc.·Product code GCJ·June 7, 2022
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
FDA Recall
Open, Classified
·Davol, Inc.·Product code GCJ·June 7, 2022
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code KCY·March 12, 2026
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
FDA Recall
Open, Classified
·TriMed Inc.·Product code LXH·September 28, 2018
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
FDA Recall
Open, Classified
·TriMed Inc.·Product code LXH·September 28, 2018
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
FDA Recall
Open, Classified
·TriMed Inc.·Product code LXH·September 28, 2018
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FRN·October 2, 2024
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
FDA Recall
Open, Classified
·TriMed Inc.·Product code LXH·September 28, 2018
TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
FDA Recall
Open, Classified
·TriMed Inc.·Product code LXH·September 28, 2018
Medtronic Reveal LINQ LNQ11 / PA96000
FDA Recall
Open, Classified
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code MXD·June 1, 2021
X80 RADiant Photoelectric Therapy System
FDA Recall
Open, Classified
·Xstrahl Limited·Product code JAD·April 27, 2022
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Recall
Open, Classified
·Conavi Medical Inc.·Product code OBJ·March 12, 2025
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.
FDA Recall
Open, Classified
·Thoratec Corp.·Product code DSQ·January 3, 2024