27 results · 30ms · Sources: EU EUDAMED, US FDA

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EPIQ Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517568533·CoRoent Ant TLIF Ti, 10x10x30mm 4°

ReLine

FDA UDI
Nuvasive, Inc.·00195377047359·RELINE-O Trial,8mm H Pedicle L-pop

Cardiovascular Procedure Kit

FDA UDI
Terumo Cardiovascular Systems Corporation·00699753513426·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694006422·1.6mm Pilot Drill, Long, Osteopower

Zodiac

FDA UDI
ALPHATEC SPINE, INC.·00844856001817·TI ALLOY PRECONTOURED ROD 5.5DIA X 40MM

ELMED

FDA UDI
ELMED INCORPORATED·00842180175815·REPLACEMENT SEALING CAP FOR OPERATING SCOPE WIT...

Bradshaw Medical Inc.

FDA UDI
Bradshaw Medical, Inc.·00810019930218·BIT, HEXALOBE 15 AO

HARDYDISK, TETRACYCLINE 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

DISPOSABLE LIGHT HANDLE AND ADAPTOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·February 11, 2020

LIFECARE PCA PLUS INFUSER

FDA Adverse Event
Injury ·HOSPIRA, INC.·Product code MEA·July 1, 2004

PENUMBRA COIL 400

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code HCG·October 24, 2014

COLLEAGUE PRE P1.7

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

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·July 1, 2013

CADD LEGACY 1 PUMPS - 6400

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·September 14, 2022

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

FDA Enforcement
Class II ·Terminated·Maquet Cardiovascular, LLC·December 29, 2021

KIDS KIT (TM) 18" ADD-ON BLOOD SAMPLING KIT

FDA Adverse Event
Malfunction ·MEDEX·Product code CBT·September 21, 2004

HLC-723 G8

FDA Adverse Event
Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024

G8

FDA Adverse Event
Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025