17 results · 20ms · Sources: EU EUDAMED, US FDA

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TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PVC Drain with Trocar

FDA UDI
C. R. Bard, Inc.·00801741050121·PVC Drain with Trocar, Medium 1/8" (10 Fr., 3.2...

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014607047·SKYTRON 3100 3" DELUXE

WOUND DRAINAGE

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code GCY·September 14, 2022

PVC DRAIN WITH TROCAR

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·August 23, 2022

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0107100·Tamp, Rotating

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345023796·Angled Tamp

PVC DRAIN WITH TROCAR

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code GCY·August 25, 2022

PVC DRAIN WITH TROCAR

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·August 23, 2022

BARD WOUND DRAIN

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·August 23, 2022

MD 10, SEM, SM 12, CBM

FDA 510(k)
FDA Class 1 ·Dental

SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES

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

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 26, 2013

PRECISION XTRA

FDA Adverse Event
Injury ·Product code NBW·May 6, 2011

ACHIEVA 1.5T NOVA

FDA Adverse Event
Other ·PHILIPS MEDICAL SYSTEMS·Product code LNH·July 9, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014