10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cure Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
SR MCP
FDA UDI
Stryker GmbH·00886385020976·S.R. MCP INSTRUMENT SET, PHALANGEAL IMPACTOR
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
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
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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