20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Optilite Low Level Albumin Kit
FDA 510(k)
FDA Class 2
·Immunology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704285437·
TROUTMAN NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896099937·TROUTMAN NEEDLE HOLDER WITH LOCK EXTRA DELICATE...
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106464·SAUER FIXATION FORCEPS 1X2 TEETH
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE
Sklar®
FDA UDI
SKLAR CORPORATION·10649111093562·SKLARCUT MAYO SCISS CVD 5 1/2"
SHASER IPL HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FORMATK MAGMA PLATFORM LASER
FDA Adverse Event
Injury
·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
FORMATK MAGMA PLATFORM
FDA Adverse Event
Malfunction
·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
STEALTHSTATION® S7
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 7, 2011
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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