84 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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MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
OsteoMed
FDA UDI
OSTEOMED LLC·00845694038744·2.0mm Champy Plate, Short, Left
LEONE SPA
FDA UDI
LEONE SPA·08033707011064·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 22
OsteoMed
FDA UDI
OSTEOMED LLC·00842528100141·2.0mm Driver Stem w/Post, Medium, Hex
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414640670·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414667363·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414667370·Automatic Disposable Biopsy Needle
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S
FDA 510(k)
FDA Class 2
·Cardiovascular
E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
145-DEG PE 42MM HUM LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·October 11, 2024
UNKNOWN BD
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 8, 2024
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
LCP METAPHYS PLATE 3.5/4.5/5 BROAD 5+7HO L19
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code LXT·June 3, 2013
DATALINK DL2000 DATA MANAGER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JQP·June 28, 2011
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 3, 2020
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 14, 2022
Centricity PACS Software Version 7.0 SP0.0.4.7
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LLZ·June 14, 2022