933 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITAL RADIOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169413603·BLADE 5102012 20MM WIDE VESSELBLADE 12CM
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193108070·HA PEEK EVOS Straight, ,12mmx8mmx 30mm , FLAT ...
RHEAD
FDA UDI
Stryker GmbH·00886385024035·Stem Implant Plasma Coated, Size 3
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0120120·Screwdriver, NIDO Assembled Screws, Sleeved
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ECG HOME
FDA 510(k)
FDA Class 2
·Cardiovascular
ETHICON
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY·Product code GCJ·May 6, 2008
ETHICON
FDA Adverse Event
ETHICON ENDOSURGERY, INC·Product code FZT·March 6, 2008
INTROCANS SAFETY
FDA Adverse Event
Injury
·B. BRAUN MELSUNGEN AG·Product code FOZ·April 25, 2013
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013
S8 ELITE - AMERICAS
FDA Adverse Event
Malfunction
·RESMED LTD.·Product code BZD·May 20, 2011
ARCHITECT I2000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code DHX·August 7, 2008
ISPAN SULFUR HEXAFLUORIDE (SF6) GAS
FDA Adverse Event
Injury
·ALCON - FORTH WORTH / ALCON LABORATORIES, INC.·Product code LPO·May 9, 2012
PERMANENT PACEMAKER ELECTRODE
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code DTB·August 12, 2023
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LWS·August 11, 2023
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code JKA·January 12, 2011
rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM INC·Product code MDS·March 31, 2014
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code OJX·August 12, 2023