22 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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BABI PLUS NEONATAL RESUSCITATION BAG
FDA 510(k)
FDA Class 2
·Anesthesiology
7930 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136020303·7930 MED ADULT M/F MASK W/1420
AcQGuide
FDA UDI
ACUTUS MEDICAL, INC.·00857042007432·AcQGuide Mini 65cm - L2 with AcQCross QX
Guider Catheter Introducer
FDA UDI
RHYTHM XIENCE, INC.·00852392007057·Guider - 65cm - L2 Guider Catheter Introducer 6...
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005230·GLOBAL ADVANTAGE ECCENTRIC HEAD SIZE 52mm x 21mm
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005209·GLOBAL ADVANTAGE HUMERAL HEAD SIZE 52mm x 18mm
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005223·GLOBAL ADVANTAGE ECCENTRIC HEAD SIZE 52mm x 18mm
Laparoscope
FDA UDI
SOPRO-COMEG GmbH·04059082032283·
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005193·GLOBAL ADVANTAGE HUMERAL HEAD SIZE 52mm x 15mm
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005216·GLOBAL ADVANTAGE HUMERAL HEAD SIZE 52mm x 21mm
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
FDA 510(k)
FDA Class 2
·Ophthalmic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·September 24, 2014
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 18, 2011
PEN NDL 32G 4MM HP 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 11, 2021
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
FDA Recall
Terminated
·Acutus Medical Inc·Product code DYB·February 25, 2020
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
FDA Recall
Terminated
·Acutus Medical Inc·Product code DYB·February 25, 2020
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
FDA Enforcement
Class II
·Terminated·Acutus Medical Inc·April 29, 2020
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
FDA Enforcement
Class II
·Terminated·Acutus Medical Inc·April 29, 2020