20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TEST, BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002660·Small Bur Hole Plate
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031275·
OptiMesh Multiplanar Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7403120064·Reduced Diameter Mesh Extender
Ø7.0 x 64mm x 120mm CANNULATED PARTIAL THREAD SCREW
FDA UDI
Osteocentric Technologies, Inc.·00816950027062·Ø7.0 x 64mm x 120mm CANNULATED PARTIAL THREAD S...
8.0 X 120mm Cann Screw Fastener 64mm Var Thd
FDA UDI
Osteocentric Technologies, Inc.·00810074306867·8.0 X 120mm Cann Screw Fastener 64mm Var Thd
AMPLATZER PFO OCCLUDER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL CATD·Product code MLV·December 4, 2019
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
BD FACS SAMPLE PREP ASSISTANT III (SPA III)
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2024
Widex
FDA UDI
Widex A/S·05706069633269·Compass V5.10.1
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 26, 2011
UNIVERSAL PLUS S/I ES STRAIGHT HANDPIECE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code GEI·August 15, 2008
4.5MM TI CURVED BROAD LCP® PLATE 13 HOLES/247MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·October 8, 2018
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
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
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025