13 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Access CT
FDA 510(k)
FDA Class 2
·Radiology
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331184901·Yasargil Micro Bipolar Bayonet Forceps, flat ha...
FISIO CHAMBER SPACE
FDA 510(k)
FDA Class 2
·Anesthesiology
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
FDA 510(k)
FDA Class 2
·General Hospital
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 2015
CRTS SM IL SG VLV ONLY
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·December 18, 2020
M2A-MAGNUM MODULAR HEAD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 21, 2014
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 19, 2011
5.5 EXP VERSE UNITIZED SET SCR
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 19, 2019
5.5 EXP VERSE SCR 6.0X45
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 19, 2019
AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016