15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
FDA 510(k)
FDA Class 2
·Orthopedic
RC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600381266·
AXOGUARD NERVE CONNECTOR AND PROTECTOR
FDA Adverse Event
Injury
·COOK BIOTECH·Product code JXI·August 24, 2015
POWDERFREE BLACK NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
U-BLADE SET, TI GAMMA3 10.5X100MM
FDA Adverse Event
Injury
·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012
AMPLATZER STEERABLE DELIVERY SHEATH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DQY·May 22, 2023
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 29, 2013
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CTR.·Product code HQC·August 22, 2008
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 17, 2011
AXOGUARD NERVE CONNECTOR AND PROTECTOR
FDA Adverse Event
Injury
·COOK BIOTECH·Product code JXI·October 24, 2019
VANGUARD XP-XP TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·September 10, 2018
AMPLATZER STEERABLE DELIVERY SHEATH
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code DQY·June 18, 2023
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021