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