17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENVOY GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII
ADSON TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896023543·ADSON TISSUE FORCEPS WITH TUNGSTEN CARBIDE SERR...
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
HANSON SCAR ADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GELSCAN, MODEL 1206
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN DVR PLATE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWJ·August 15, 2017
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
CATHETER MOUNT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZO·August 6, 2014
V40 COCR LFIT HEAD 36MM/0
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·October 3, 2014
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·May 31, 2013
ENDO GIA ROTICULATOR 45-4.8 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·June 15, 2011
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019