23 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Freeprint denture
FDA 510(k)
FDA Class 2
·Dental
JACOBSON HEMOSTATIC FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060920·JACOBSON HEMOSTATIC FORCEPS DELICATE CURVED TIP
OsteoMed
FDA UDI
OSTEOMED LLC·00845694043083·1.6mm Extended Pilot Drill, 8mm Stop, J-Latch
ACUMED
FDA UDI
Acumed LLC·10806378014284·3.5mm x 38.0mm Locking Cortical Screw
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742709·Mini-Hohmann Retractor 6-1/4" (15.6cm), blade 8...
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964109447·Custom Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964102103·Endo Carry-On Procedure Kit
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964109454·The ENDO CARRY-ON Procedure Kit contains all of...
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964102431·Trial Procedure Kit
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964109317·Custom Procedure Kit
ACUMED
FDA UDI
Acumed LLC·10806378014291·3.5mm x 38.0mm Locking Cortical Screw
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
microTargeting™ Spacer Tube
FDA UDI
FHC, INC.·00873263004616·microTargeting IT(AR2) Spacer Tube, nonsterile
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 24, 2014
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2013
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDW·July 22, 2016
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018