14 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112397·BARD-PARKER HANDLE #9
Schoelly Cystoscopes/Hysteroscopes and Accessories
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112366·CHUCK HANDLE #3K 10CM LONG
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112373·CHUCK HANDLE #3KA 7.5CM LONG
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
FDA 510(k)
FDA Class 2
·Orthopedic
JET 1 POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
RAD-G
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 29, 2019
DBS SINGLE EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014
TAPERGUARD EVAC
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code BTR·August 4, 2011
DUROM ACETABULAR COMPONENT 58/52 CODE R
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 26, 2013
5.0MM CANNULATED CONICAL SCREW 50MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·June 21, 2019
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023