19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOFIA Plus Aspiration Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ANA 2000 Capsules 3 Spill 50 count
FDA UDI
Wykle Research, Inc·00853383006837·
Pulse® LOGIC™
FDA UDI
INNOVATIVE HEALTHCARE CORPORATION·00813172023490·Gloves, Exam, Nitrile, Non-Sterile, Powder-Free...
AOS HUMERAL NAIL 9.0mm x 20cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016956·
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100813·FLIERINGA FIXATION RING 20MM
BAK®
FDA UDI
ZIMMER SPINE, INC.·00889024333338·
PROPEP DELIVERY DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 10, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 10, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 5, 2023
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·August 5, 2020
OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·September 12, 2025
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013
DISCOVERY II
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code NVZ·July 23, 2011
OPTETRAK LOGIC FIT TIBIAL TRAY, CEMENTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 19, 2014
SNORERX
FDA Adverse Event
Injury
·APNEA SCIENCES·Product code LRK·May 22, 2017
ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 20, 2025
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024