14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664223144·ULTRA SHEER 20-30 MM HG THIGH W/DOT BAND CLOSED...
Bernafon
FDA UDI
Bernafon AG·05711584022719·MD1 NR, PS BE MONDO 1
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113591·PS-C Insert, Size 3 x 14mm
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016395·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14m...
3M INTEGRATED CYCLER (110V) & (220V)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SANARUS VISICA TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMPT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 13, 2011
ARCHITECT B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·September 22, 2025