18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PICCOLO MAGNESIUM TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040115·RING PESSARY W/O SUPPORT #5
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001854·Wrist Splint
HiRise
FDA UDI
CURVEBEAM, LLC·00860004550020·CBCT upper & lower extremities including the pe...
20GA Curved Illuminating Probe, SMA906
FDA UDI
Peregrine Surgical, Llc·00632307002014·20GA Curved Illuminating Probe, SMA906
n/a
FDA UDI
Ortho Development Corporation·00822409073818·10/12 Resection Guide 30degx15mm
Arthrex®
FDA UDI
ARTHREX, INC.·00888867522107·Cannulated Cancellous Screw, 7.0x115mm
BD ULTRA-FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 7, 2022
Toilet Support Arms
FDA UDI
Ropox A/S·05707581000287·
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RETIC CHEX LINEARITY
FDA 510(k)
FDA Class 2
·Hematology
12/14 ARTICUL 40MM M SPEC-2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 8, 2013
2124215-2011-00478
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVN·April 5, 2011
ARTICUL/EZE BALL 32 + 1 GR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code JDI·May 7, 2008
ULTRA 2 CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010
Stryker Epic Zoom Critical Care Bed -Model 2040, 115 V, 500 lbs ( 227 Kg) Stryker, Portage Mi 49002 Product Usage: EPIC II (model 2040) Critical Care beds is primarily used in a Critical Care environment, but may be used in Med/Surg environments.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FNL·March 12, 2012
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020