17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20415401·Arch wires Titanol Superelastic Straight-Arch-F...
JEDMED
FDA UDI
JEDMED INSTRUMENT COMPANY·M6330415400·"S-II" Chair Manual Base
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
FDA 510(k)
FDA Class 2
·Cardiovascular
RUSCH EDGAR TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFESHIELD LATEX FREE SYMBIQ PUMP SET
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2012
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 1, 2010
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·January 7, 2011
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·April 8, 2013
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·March 10, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 10, 2025
THERAPY ABLATION CATHETER
FDA Adverse Event
Malfunction
·IRVINE BIOMEDICAL, INC.·Product code LPB·October 17, 2008
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024