19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WowGoHealth Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dandy Clear Aligners
FDA UDI
Orthly, Inc.·00860006891206·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294194·
NA
FDA UDI
KEY SURGICAL, INC.·10849771050268·Steinmann Pins, Single trocar threaded, 5/32-in...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771015765·Steinmann Pins, Single trocar threaded, 5/32-in...
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018692·Obturator 4.0 x 175mm pyramid tip
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018708·Arthroscope shaft 2.7mm, 2 rigid stop cocks
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
FREEDOM(R) STEMMED TIBIAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 17, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 22, 2011
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024
SOLITAIRE FR2
FDA Adverse Event
Death
·COVIDIEN (IRVINE)·Product code NRY·September 29, 2017
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019
SCEPTER XC
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code DQY·December 6, 2023
SOLITAIRE FR2
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code NRY·September 29, 2017
PEDICLE SCREW 6X45
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021