28 results
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23ms
·
Sources: EU EUDAMED, US FDA
3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
FDA 510(k)
FDA Class 2
·General Hospital
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10198459185588·IUD INSERTION
HHM
FDA UDI
Oticon A/S·05707131165060·K130, BTE 13 P STG HHM
FINOCHIETTO RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896090736·FINOCHIETTO RETRACTOR MEDIUM SIZE SPREAD
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383501538·Gutta Percha Points is used to root canal filin...
Recon
FDA UDI
Revelation Medical Devices·G31810152802·Double B Retractor
Recon
FDA UDI
Revelation Medical Devices·G31810152801·MIS Hip Acetabular Retractor Single Prong
NAMBUCCA Anterior Lumbar Plate Screw
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215019945·
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PC FLOW +
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2024
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013
2PC VEN SYS W/PRT LCK 4NDLE OD 2.5MM 9FR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code LJT·September 19, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 25, 2011
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012