42 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756619011·EXTRICATION COLLAR
Professional Surgical Instruments Co., Inc.
FDA UDI
Professional Surgical Instruments Co., Inc.·00853863007026·Utility Scissors 7.5" Black
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122209·KWire .045x4" (1.1x100mm)
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702556919·ELVAREX 3/KNEE HIGH/SLANT-CLOSED TOE/SOFTFIT/GREY
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702256895·E2/AG/SL-CT-E-KC/NOP5-T/BL
HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GLUCOSE (HEXOKINASE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EASY TOUCH LANCING DEVICE
FDA Adverse Event
Injury
·Product code FMK·May 14, 2013
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 23, 2014
RELION MICRO BLOOD GLUCOSE SYSTEM
FDA Adverse Event
Injury
·ARKRAY, INC.·Product code CGA·June 2, 2011
LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
LOGIC CR TIB INSERT STD, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·November 2, 2022
LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 10, 2025
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 18, 2024
LGC TIBIAL FIT TRAY CEM SZ 4F / 4T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
LOGIC CR FEMORAL CEM, RIGHT, SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
THREE PEG PATELLA 32MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 21, 2023