22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cetro America Ultrasound Transducer for IM77/AM67
FDA UDI
CETRO AMERICA INC·00852519007014·Replacement ultrasound transducer for Advanced ...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193107738·HA PEEK EVOS Straight, ,11mmx11mmx 30mm , FLAT ...
DIASWISS S.A.
FDA registration
DIASWISS S.A.·9 products·🇨🇭 Switzerland
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0110110·Sounder, Ball Tip, Straight, Firm, Titanium
Ocata Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07308K0110110·Guide, Drill Only, Variable
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620310110·Quad Channel Met-Traverse, 31mm x 11mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2711020310110·Lateral Midfoot Charcot Guide, 30mm x 11mm
DIAMONDCOAT ULTRASONIC INSERTS
FDA 510(k)
FDA Class 2
·Dental
LIVESURE MORPHINE SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·October 15, 2025
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 28, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 16, 2014
GENIE
FDA Adverse Event
Injury
·SHEALTHCARE INC.·Product code ELW·March 16, 2011
DYNESYS LIS, STABILIZING CORD, 200
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code NQP·May 2, 2019
EQT
FDA Adverse Event
Injury
·MAQUET SAS·Product code FXR·January 15, 2026
EQT
FDA Adverse Event
Injury
·MAQUET SAS·Product code FXR·January 13, 2026
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016