159 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
FDA 510(k)
FDA Class 2
·Anesthesiology
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code CBK·April 18, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
K121116
FDA UDI
Life Spine, Inc.·00190837016029·
COMPREHENSIVE®
FDA UDI
Biomet Orthopedics, LLC·00880304456563·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016043·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016258·
Axiom®
FDA UDI
AXIOM MEDICAL, INCORPORATED·M6651111160·Mediastinal Drain, Silicone, Eyes On Top
SURESIGNS VS2+ NBP/SPO2/WIRELESS
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
FDA 510(k)
FDA Class 2
·Cardiovascular
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
FDA 510(k)
FDA Class 2
·Microbiology
Widex
FDA UDI
Widex A/S·05706069885828·WIDEX MOMENT MRB0 (Dark cherry ) 110, RIC 10
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321111160·
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046003432·FG Rotary diamond instrument for dental applica...
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046038116·FG Rotary diamond instrument for dental applica...
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046317513·Rotary diamond instrument for dental application
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046112743·FG Rotary diamond instrument for dental applica...
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046284070·Rotary diamond instrument for dental application
MDT Diamond Coated Dental Burs -Sterile
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·67291046145892·FG Rotary diamond instrument for dental applica...
MDT Diamond Coated Dental Burs -Sterile
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·67291046234992·FG Rotary diamond instrument for dental applica...