16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hive Stand-alone Anterior Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
FDA UDI
NANOVIS SPINE, LLC·00814216027887·ANATOMIC PEEK w/ Nano 14 x 11 x 5 x 10°
ELMED
FDA UDI
ELMED INCORPORATED·00842180102736·BIPOLAR RF-CABLE WITH EVEREST / CIRCON INSTRUME...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694053785·Fracture Plate Organizer Block
AGILITY ANKLE REVISION PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
SILK NONABSORBABLE SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
GUIDEWIRE 0.018 4/320CM ANGLED (STRAUB MEDICAL)
FDA Adverse Event
Malfunction
·STRAUB MEDICAL AG·Product code DQX·November 5, 2020
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·October 24, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·July 1, 2013
BD PLATE CAMPYLOBACTER SB 100MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024
MECTALIF TRANSFORAMINAL CAGES TIPEEK
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025
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
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014