18 results
·
31ms
·
Sources: EU EUDAMED, US FDA
SURGI-VISION GUIDEWIRE COIL
FDA 510(k)
FDA Class 2
·Radiology
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085022864·Sodium Hydroxide Solution (4%)
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003338·Cardiovascular Needle Holder Diamond Dust™
Selectra
FDA UDI
ELITechGroup B.V.·03661540600401·
BELLEGLASS HP TRANSLUCENT DENTIN
FDA 510(k)
FDA Class 2
·Dental
AGILENT M2636A TELEMON MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 5, 2025
REFORM 6.5 X 45MM POLYAXIAL PEDICLE SCREW
FDA Adverse Event
Injury
·PRECISON SPINE, INC·Product code MNH·March 24, 2015
POLYAXIAL DRIVER, REFORM
FDA Adverse Event
Injury
·PRECISION SPINE, INC.·Product code HXX·March 24, 2015
POLYAXIAL DRIVER, REFORM
FDA Adverse Event
Injury
·PRECISION SPINE, INC·Product code HXX·March 24, 2015
HOHMANN STYLE ARM 183MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·February 28, 2013
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MZV·March 1, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·February 21, 2008
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Recall
Terminated
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JGS·January 10, 2012
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022