12 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spring Coil Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
SPSMEDICAL SPORVIEW PA CULTURE SET
FDA 510(k)
FDA Class 2
·General Hospital
UNISTRIP 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code MXC·January 13, 2014
TM MONOBLOCK TIBIA
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·May 29, 2013
VC EVH, OD, SMR, VD, BP
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code GEI·June 17, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 15, 2018
PKG, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
OT ULTRA MINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·June 18, 2021
OT ULTRA MINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·June 18, 2021
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017