50 results · 21ms · Sources: EU EUDAMED, US FDA

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OralTox Oral Fluid Drug Test

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium

Ophthalmic Ring

FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383552547·Gutta Percha Points is used to root canal filin...

Life Instruments

FDA UDI
Life Instrument Corporation·M93071714030T10·14" Thoracic Curette #3 Str w/teeth 5" handle

ELI 250 ELECTROCARDIOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

ULTRATHANE COPE NEPHROURETEROSTOMY SET

FDA Adverse Event
Injury ·COOK INC·Product code FAD·February 22, 2022

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013

FRAXEL SR 1500 LASER SYSTEM

FDA Adverse Event
Injury ·RELIANT TECHNOLOGIES, INC.·Product code GEX·February 22, 2007

RESTORE PRIME ADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.,·Product code LGW·September 17, 2008

PRONTO SPOT CHECK PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

ULTRATHANE COPE NEPHROURETEROSTOMY SET

FDA Adverse Event
Injury ·COOK INC·Product code FAD·June 7, 2021

ULTRATHANE COPE NEPHROURETEROSTOMY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·September 28, 2023

ULTRATHANE AMPLATZ URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·September 11, 2020

ULTRATHANE COPE NEPHROURETEROSTOMY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·December 22, 2020

ULTRATHANE COPE NEPHROURETEROSTOMY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·October 16, 2020

ULTRATHANE COPE NEPHROURETEROSTOMY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·May 5, 2022

ULTRATHANE COPE NEPHROURETEROSTOMY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·August 31, 2022