20 results · 22ms · Sources: EU EUDAMED, 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