16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HD Video Rhino Laryngoscope
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pantheon PFR System
FDA UDI
ADLER ORTHO SPA·08052275306228·Pantheon Salvage Plate with Spikes Compression ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694034685·Low Profile Implant Caddy
Metra 49-98001-4 - 24 Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588079400·Metra 49-98001-4 - 24 Poly White
Brophy Tissue Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896118720·Brophy Tissue Forceps Fine Cross-Serrated 1x2 T...
LFI NASAL MUCOSA RETRACTOR
FDA UDI
W.H. Holden, Inc.·D9282007400·
ROCHE ONLINE THEOPHYLLINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2024
TTAP SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 28, 2018
VANGUARD PS TIBIAL BEARING 12X71/75MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·July 1, 2013
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 3, 2013
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021