21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OIC External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
LuxaPrint Ortho Plus 385
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1712110·(Meth) acrylate-based light-curing resin exclus...
LuxaPrint Ortho Plus 385
FDA UDI
DMG Digital Enterprises SE·D9821712110·(Meth) acrylate-based light-curing resin exclus...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049408·K-Wires, Double diamond, .035-inch (0.9mm) diam...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293036·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484542·K-Wire w. double end lanzet point _x000D_...
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158212664·UTERINE CURETTE SIMS SHARP FLEXIBLE FIG. 4 11.5...
K-Wire w. double end lanzet point 0.9mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712110·K-Wire w. double end lanzet point
0.9mm/...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383552622·Gutta Percha Points is used to root canal filin...
VACUTRON
FDA UDI
Allied Medical, LLC·00026072010068·
COBAS C 111 ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CELL-DYN 22 PLUS CONTROL
FDA 510(k)
FDA Class 2
·Hematology
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·October 2, 2023
ISA CO2
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022
COULTER ACT 5DIFF CAP PIERCE (CP)
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 14, 2013
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 22, 2008
COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·June 2, 2025
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014