21 results · 26ms · Sources: EU EUDAMED, US FDA

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ADMIRE

FDA 510(k)
FDA Class 2 ·Radiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517575487·CoRoent Ant TLIF Ti, 15x13x36mm 0°

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100301·INFANT WIRE SPECULUM 3MM/5MM BLADES

Sklar®

FDA UDI
SKLAR CORPORATION·10649111059056·SKLHN PLAST SCIS STR 4 3/4"

AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C

FDA 510(k)
FDA Class 2 ·Anesthesiology

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 27, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 3, 2024

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019

STEALTHSTATION S7 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018

OMNIPOD INSULIN PUMP

FDA Adverse Event
Other ·INSULET CORPORATION·Product code LZG·February 13, 2009

MCGHAN 153 3600CC

FDA Adverse Event
Injury ·ALLERGAN·Product code FTR·November 18, 2019

CART 9734056 S7 STAFF SHRT 100-120V INTL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

STEALTHSTATION® S7

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MPRI·Product code LWS·June 8, 2013

LAMITRODE 44C 60-CM LENGTH PADDLE LEAD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011

PRONTO SHORT EXTRACTION CATHETER

FDA Adverse Event
Injury ·VASCULAR SOLUTIONS, INC.·Product code DXE·September 5, 2008

FREESTYLE PRECISION NEO H

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

Comprehensive Reverse Shoulder System Humeral Tray Model 115340

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·February 22, 2017