27 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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THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
FDA 510(k)
FDA Class 2
·Orthopedic
Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989025767·NITI CR TRU-ARCH 14 DIA UPR MED-BP/100
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481114731·LOCATOR F-Tx Abutment for Regular Platform (RP)...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110559·LOCATOR R-Tx Abutment for Regular Platform (RP)...
Invotec Tracheal T-Tube
FDA UDI
INVOTEC INTERNATIONAL, INC.·00818501020089·Invotec Tracheal T-Tube, Non-Sterile, 10.0cm Long
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128721·LOCATOR R-Tx Abutment, Regular Platform (RP) Tr...
P102, S102, 1 FT, NO DP, CURBELL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828129480·P102, S102, 1 FT, NO DP, CURBELL
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code CBK·September 2, 2015
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 10, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 30, 2014
UNKPROWLERSELECT
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code KRA·October 5, 2021
BD FACS 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020
2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2023
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·October 23, 2024