18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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restor3d TiDAL Lumbar Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005725·Cassette - Filter, Male Neuraxial Connector
ambIT* Cassette - Filter, Male Neuraxial Connector
FDA UDI
Avanos Medical, Inc.·00193494000387·ambIT* Cassette - Filter, Male Neuraxial Connector
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540366795·Drill Guide, Eccentric, For 2.3mm Screws
LEONE SPA
FDA UDI
LEONE SPA·08033707022503·CALIBRA BANDS 2ND MOLAR n.SUR 23
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134408·LATERAL,RONGEUR,PITUITARY,6
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
FDA 510(k)
FDA Class 2
·General Hospital
Biolign® Roto-Loc Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN BD NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·March 18, 2024
NONE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·October 29, 2008
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 23, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021