16 results · 25ms · Sources: EU EUDAMED, 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