15 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911050152·TRACH TUBE, AIR-LON - SIZE 4
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124788·Modular Stem 15mm x 125mm
Batrik Brush/Green/BD 15+20mm/BL 50mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521007772·Brush/Green/BD 15+20mm/BL 50mm/OL 50cm - Asymet...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450141045·
KIPPMED I.V. MANIFOLD
FDA 510(k)
FDA Class 2
·General Hospital
SYNTHES VERTEBRAL SPACER TI
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 26, 2020
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·April 10, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011
SOVEREIGN COMPACT
FDA Adverse Event
Injury
·ADVANCED MEDICAL OPTICS (AMO)·Product code HQC·May 20, 2008
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 20, 2022
Tracheostomy Tubes, Air Lon Nylon, item number 1050150 size 3, item number 1050152 size 4, item number 1050154 size 5, item number 1050156 size 6, item number 1050158 size 7, and item number 1050160 size 8.
FDA Recall
Terminated
·Premier Dental Products Co·Product code JOH·August 5, 2004
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022