21 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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FLEXITIME FAST & SCAN LIGHT FLOW
FDA 510(k)
FDA Class 2
·Dental
Unity Total Knee System
FDA UDI
CORIN LTD·05056139243363·UNITY KNEE™ PS-C INSERT - Size 9 x 14mm
ArgenPMMA Multi 98x14-BL
FDA UDI
ARGEN CORPORATION, THE·D818120914·Crown And Bridge, Temporary, Resin
Mini Unicycle™
FDA UDI
Ortho Organizers, Inc.·00190707056971·Mini Unicycle™ .120” Ligature Ties - Cobalt Blue
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450443927·
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521209140·
TALOS®-C
FDA UDI
SpineArt SA·07640375236500·STERILE TALOS®-C (HA) PEEK PLANAR IBFD
TQ HBA1C GEN3
FDA 510(k)
FDA Class 2
·Hematology
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
FDA 510(k)
FDA Class 2
·Hematology
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 12, 2013
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 13, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·September 26, 2014
COULTER ® LH750
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·June 12, 2011
SYRINGE ENTERAL 10ML BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 12, 2020
SYRINGE ENTERAL 10ML BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 1, 2019
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion
447 March Road
Ottawa Canada Ontario·Product code NAW·February 24, 2009
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OEQ·June 11, 2024