23 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRON
FDA 510(k)
FDA Class 2
·Radiology
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G22312212300·Chang Microfinger Chopper & Vertical Safety Cho...
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024400504·
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123209170·Castroviejo Needle Holder TC, Straight, Flat Ha...
IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE
FDA 510(k)
FDA Class 2
·Dental
HERO
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPTURE-R READY-ID
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·January 22, 2019
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·November 5, 2008
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE·Product code ITI·August 24, 2011
ACCU-CHEK ® SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 11, 2013
ONCOLOGY SALVAGE SYSTEM - NON-MOD PROX TIB 5CM 9X150
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017
FINN KNEE PROSTHESIS - FEMORAL BUSHING SET OF 2
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·December 23, 2021
ONCOLOGY SALVAGE SYSTEM - REINFORCED YOKE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017
FINN KNEE PROSTHESIS - LOCK PIN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BMT SPLINED KNEE STM 14X120
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 31, 2017
ONCOLOGY SALVAGE SYSTEM- TIBIAL POLY BEARING 12MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 5, 2017
FINN KNEE PROSTHESIS - AXLE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017
DISPOSABLE ELECTROSURGICAL SNARE
FDA Adverse Event
Malfunction
·AOMORI OLYMPUS CO., LTD.·Product code FDI·December 1, 2023
Stryker Secure Model 3221, 230 V- 50/60 Hz, 500 lbs (227 Kg) Stryker, Kalamazoo, MI 49001 Product Usage: Secure II (model 3221) Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The Secure II model is primarily used in the Med/Surg units, but may also be found in a Critical Care environment. . Models 3221 represents International Voltage configurations of the 3002 model.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FNL·March 12, 2012