20 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RANDOX GLUCOSE (GOD/PAP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964023048·The ENDO CARRY-ON Procedure Kit contains all of...
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159024135·LEGACY Jacobson Titanium Micro Needle Holder
QUASAR
FDA UDI
Modus Medical Devices Inc·G34350033460·RESP-Split Cedar Dual Tumour Insert
EZ CONNECT
FDA 510(k)
FDA Class 2
·Dental
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 21, 2013
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 21, 2013
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 23, 2015
2520274-2013-10930
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MNI·February 28, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 1, 2011
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Other
·STAAR SURGICAL CO.·Product code HQL·February 27, 2008
UNK ATTUNE KNEE TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·June 14, 2024
UNK ATTUNE KNEE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·June 14, 2024
UNK ATTUNE KNEE PATELLA
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·June 14, 2024
UNK ATTUNE FEMORAL
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·June 14, 2024
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 20, 2013
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024