23 results · 31ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777655·LUMBAMED BASIC DORSAL STAYS M SILVER III

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777600·LUMBAMED BASIC DORSAL STAY WM SILVER III

Drill Guide

FDA UDI
Treace Medical Concepts, Inc.·00810111223720·Drill Guide and Template

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114261·CHAMBER MAINTAINER 23GA (PK/10)

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112588·BARRON CORNEAL PUNCH 6.75MM

N/A

FDA UDI
NORTHGATE TECHNOLOGIES INC.·00817183020714·CO2 Shuttle Valve System, Insufflation

SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

INSTAFLO BOWEL CATHETER SYSTEM KIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 26, 2020

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

REPERFUSION CATHETERS ZOOM 71; ZOOM 55; ZOOM 45

FDA Adverse Event
Injury ·IMPERATIVE CARE INC.·Product code NRY·July 17, 2025

REPERFUSION CATHETERS ZOOM 71; ZOOM 55; ZOOM 45

FDA Adverse Event
Injury ·IMPERATIVE CARE INC.·Product code NRY·July 17, 2025

REPERFUSION CATHETERS ZOOM 71; ZOOM 55; ZOOM 45

FDA Adverse Event
Injury ·IMPERATIVE CARE INC.·Product code NRY·July 17, 2025

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 9, 2016

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 24, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 1, 2013

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·August 28, 2018

LIGACLIP*EXTRA TITANIUM CLIPS

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 12, 2018