162 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517636850·CoRoent Ant TLIF PEEK, 13x10x28mm 15°
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584993·Apex Tibial Nail Ø 13 x 285mm
LITETOUCH MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016
LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·May 22, 2013
ASAHI FIELDER PTCA GUIDE WIRE
FDA Adverse Event
Injury
·AV-ASAHI·Product code DQX·September 30, 2014
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·June 13, 2011
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 15, 2024
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017
TSRH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017
Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
FDA Enforcement
Class II
·Ongoing·Stryker Neurovascular·June 5, 2024
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021