100 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD Alaris System with Guardrails Suite MX v12.1.2
FDA 510(k)
FDA Class 2
·General Hospital
Comprehensive® SRS
FDA UDI
Biomet Orthopedics, LLC·00880304540811·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112297·HALO, 1203-5 VEST MEDIUM, LAMBSWOOL LINER, 1211...
Clavicle Plate
FDA UDI
I.T.S. GmbH·09120034304415·Clavicle Plate, 8-Hole
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001312112180·Retention Plate, Oblique-Only, Small, 12 mm - 1...
COMPR SRS PROX BDY - LG 42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·February 28, 2018
COMPR SRS MOD STEM - 16X75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·January 31, 2018
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
FDA 510(k)
FDA Class 2
·Orthopedic
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARCOM XL 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 28, 2023
SYNCHROMED II
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code LKK·October 24, 2008
OLYMPUS EVIS EXERA II VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·July 12, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 8, 2013
CLAVICLE PLATE, 2.5MM, 8-HOLE
FDA Adverse Event
Malfunction
·I.T.S. GMBH·Product code HRS·January 8, 2019
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 31, 2025
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·August 30, 2017
COMPREHENSIVE SRS MODULAR STEM 12X75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 21, 2017
ARCOM XL 44-41 RTNV +3 HMRL BR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·January 31, 2018
UNKNOWN DISCOVERY HUMERAL CONDYLE KIT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·June 21, 2018
COMP RVS CNTRL 6.5X30MM ST/RST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 31, 2018