16 results
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59ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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heartscare B-Ketone Test Strips (10pcs/Box)
FDA UDI
Hearts Bio, Inc.·00850014861681·
HeartsCare C1 Plus Multi-Functional Monitoring System
FDA UDI
Hearts Bio, Inc.·00850014861575·
HeartsCare LACTATE TEST STRIPS (25PCS/BOX)
FDA UDI
Hearts Bio, Inc.·00850014861537·
HeartsCare C1 Total Cholesterol Test Strip (10pcs/box)
FDA UDI
Hearts Bio, Inc.·00850014861346·
HeartsCare C1 monitoring system
FDA UDI
Hearts Bio, Inc.·00850014861049·
HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)
FDA UDI
Hearts Bio, Inc.·00850014861360·
HeartsCare C1 Plus Multi-Functional Monitoring System
FDA UDI
Hearts Bio, Inc.·00850014861056·
heartscare Total Cholesterol Test Strip (10pcs/box)
FDA UDI
Hearts Bio, Inc.·00850014861834·
HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX)
FDA UDI
Hearts Bio, Inc.·00850014861629·
HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)
FDA UDI
Hearts Bio, Inc.·00850014861353·
HeartsCare LACTATE TEST STRIPS (10PCS/BOX)
FDA UDI
Hearts Bio, Inc.·00850014861407·
HEARTMATE 3 LVAS MINI APICAL CUFF KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 11, 2019
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·April 22, 2024
INQUIRY¿ STEERABLE EP CATHETER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code DRF·May 24, 2023
V.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code OMP·June 26, 2012
TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA Product is a medical device, a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. tis function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, MMode, Pulsed(PW) Doppler mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or harmonic imaging and 3d/4d imaging on a flat panel display. The device system is intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The device is a multi frequency, multi plane, phased sector array transducer. In the TEE (transesophageal echocardiography process where the device fails, the transducer is introduced into the esophagus of the patient to obtain images of the heart structure.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYO·April 7, 2009