29 results
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27ms
·
Sources: EU EUDAMED, US FDA
QUANTUM RING FIXATION SYSTEM MODEL ISF
FDA 510(k)
FDA Class 2
·Orthopedic
Invivo
FDA UDI
Philips Ds North America LLC·00884838081529·1.5T KFA with coil ID
Innovo
FDA UDI
SCOTTCARE CORPORATION, THE·00856298006060·Cardiac Rehab ECG telemetry transmitter.
Sklar®
FDA UDI
SKLAR CORPORATION·10649111377990·TRAY PERF 20.75 X 12.75 X 2.5
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973271·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971178·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172972991·
RADIUS NEXT GENERATION GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973646·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973561·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 2, 2026
VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 11, 2022
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013
S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) MOLDABLE WAFER
FDA Adverse Event
Injury
·CONVATEC, INC.·Product code EXE·September 15, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 10, 2011
MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 16, 2016
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·March 9, 2016