11 results
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19ms
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Sources: EU EUDAMED, US FDA
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
FDA 510(k)
FDA Class 2
·Cardiovascular
Costco
FDA UDI
Bernafon AG·05711584089163·CAPTO 3 MNR, 2.4G NFM PB MAC/MSIL COSTC
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·March 31, 2016
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
FDA 510(k)
FDA Class 2
·Cardiovascular
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
RAD-8
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 15, 2015
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
CONSERVE(R) SF CEMENTED FEMORAL COMPONENT
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KXA·October 22, 2014
SROM MAR LNR M 28MM+3MM 10 DEG
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code KWA·June 27, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024