17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wireless Smart Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
MECTALIF TIPEEK
FDA 510(k)
FDA Class 2
·Orthopedic
RH-950
FDA 510(k)
FDA Class 2
·Physical Medicine
M.U.S.T. PEDICLE SCREW 7X45
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MNI·January 20, 2017
PEDICLE SCREW 03.50.030 PEDICLE SCREW 7X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·February 3, 2020
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·July 22, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013
MECTALIF POSTERIOR
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·October 8, 2025
MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X7 L0°
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·November 10, 2017
MECTALIF (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·April 29, 2020
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·May 23, 2019
MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·May 25, 2023
PEDICLE SCREW PEDICLE SCREW 6X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·September 21, 2018
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 19, 2012
MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·October 17, 2018
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014