25 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN
FDA 510(k)
FDA Class 1
·Physical Medicine
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112793·BARRON VACUUM PUNCH 8.5MM
Orthopaedic Surgical Instruments
FDA UDI
CITIEFFE SRL·08056711921136·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100110001·IN-OVATION® C TGO 020X028 U5-5/L3-3 CS-BC HK
FIXED 45 DEGREE INCLINED BINOCULAR, A-SERIES, 10X EYEPIECES, F:160
FDA UDI
GLOBAL SURGICAL CORPORATION·00810040250316·
BD PHOENIX¿ PID
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LQL·October 12, 2023
Viceroy
FDA UDI
DIOMEDICAL CO.,LTD.·08800039825900·Rod 5.5 x 110mm
SPL CRIMP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DRI ECSTASY ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 23, 2013
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·September 19, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
FDA Recall
Completed
·Product code LHO·February 8, 2024
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
FDA Enforcement
Class II
·Completed·Landauer·March 27, 2024
Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013