29 results · 23ms · Sources: EU EUDAMED, US FDA

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POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902941498·INSTRUMENT 8161008 S STPL OPNR 2 4 PRNG

Cohere

FDA UDI
Nuvasive, Inc.·00195377028129·COHERE TLIF-O Trial, 16x10mm 8°

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304250734·

Mui Scientific

FDA UDI
H & A Mui Enterprises Inc·10678467504637·Customized Single-Use 16ch Esophageal Catheter

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122254·KWire .062x4" (1.6x100mm)

Xenix Medical Universal Handle

FDA UDI
XENIX MEDICAL LLC·00840493413860·HANDLE, MEDIUM AXIAL FIXED, 7 CANN, MACHINED

QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199

FDA 510(k)
FDA Class 1 ·Microbiology

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY

FDA 510(k)
FDA Class 2 ·Radiology

ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

CLEARLINK CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 6, 2021

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

CARELINK

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

TEMPERATURE/FLOW PROBE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 13, 2011

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·September 19, 2018

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·March 8, 2021

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·January 11, 2018