11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPI 3 Hb A1c
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SR MCP
FDA UDI
Stryker GmbH·00886385020969·S.R. MCP INSTRUMENT SET, METACARPAL IMPACTOR
STERRAD 100NX TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
AIM 200, MAJOR SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code KNW·March 12, 2026
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 21, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·September 18, 2008
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code LWE·October 8, 2025
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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