28 results
·
21ms
·
Sources: EU EUDAMED, US FDA
NOTOUCH BREASTSCAN
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
5530 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136020983·5530 3L CAL SYR SPEC OD MIR
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795001965·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024500501·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970584·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970126·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970591·
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
FDA 510(k)
FDA Class 2
·Ophthalmic
ARCHITEX SPACE MAINTENANCE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
T:SLIM G4 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·October 25, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2026
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
UNKNOWN MESH PRODUCT (EWHU)
FDA Adverse Event
Injury
·ETHICON·Product code FTL·June 3, 2011
Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
STERILE FX25RWC W/ RES
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·March 14, 2023
STERILE FX25RWC W/ RES
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·August 4, 2023
NS FX25RWC W/RES
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·July 13, 2023
CAPIOX RX25 OXYGENATOR WEST
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·December 21, 2021
STERILE FX25RWC W/ RES
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·April 5, 2023