43 results · 22ms · Sources: EU EUDAMED, US FDA

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Picocaremajesty

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LuxaCore® Automix Dual

FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2121270·Core cuild-up composite. Core buildups and post...

NA

FDA UDI
Synthes GmbH·10886982152015·3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...

CADD

FDA UDI
ICU MEDICAL, INC.·15019517150292·

PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PULSEMASTER ERBIUM DENTAL LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FRN·February 11, 2026

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FRN·February 10, 2026

CADD

FDA UDI
ICU MEDICAL, INC.·15019517126600·

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FRN·April 14, 2026

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2120-0102-14 21-2120-0102-15 21-2120-0102-17 21-2120-0102-237 21-2120-0102-238 21-2120-0102-247 21-2120-0102-249 21-2120-0102-51 21-2120-0102-78 21-2120-0102-92 21-2120-0102-97 21-2120-0102-98 21-2120-0103-01 21-2120-0103-02 21-2120-0103-03 21-2120-0103-06 21-2120-0103-07 21-2120-0103-08 21-2120-0103-12 21-2120-0103-14 21-2120-0103-15 21-2120-0103-17 21-2120-0103-249 21-2120-0103-51 21-2120-0103-78 21-2120-0104-01 21-2120-0104-231 21-2120-0105-00 21-2120-0105-01 21-2120-0105-02L 21-2120-0105-03L 21-2120-0105-06L 21-2120-0105-07L 21-2120-0105-08 21-2120-0105-08L 21-2120-0105-12L 21-2120-0105-13L 21-2120-0105-14L 21-2120-0105-15L 21-2120-0105-17L 21-2120-0105-50 21-2120-0105-50L 21-2125-0104-01 21-2125-0105-03L 21-2125-0105-07L 21-2125-0105-08L 21-2125-0105-50L 21-2127-0104-01 21-2127-0105-01 21-2127-0105-02L 21-2127-0105-03L 21-2127-0105-06L 21-2127-0105-08L 21-2127-0105-50L

FDA Recall
Open, Classified ·Smiths Medical ASD, Inc.·Product code FRN·April 10, 2025

FLOGARD

FDA Adverse Event
Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·October 29, 2014

CENTRA BED

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·July 8, 2011

TOTAL ASR ACET IMP SIZE 52

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 8, 2013

CADD

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·April 1, 2022

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 Recall
Terminated ·Smiths Medical ASD Inc.·Product code FRN·March 24, 2020

CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD S

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·May 30, 2022

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2120-0102-14 21-2120-0102-15 21-2120-0102-17 21-2120-0102-237 21-2120-0102-238 21-2120-0102-247 21-2120-0102-249 21-2120-0102-51 21-2120-0102-78 21-2120-0102-92 21-2120-0102-97 21-2120-0102-98 21-2120-0103-01 21-2120-0103-02 21-2120-0103-03 21-2120-0103-06 21-2120-0103-07 21-2120-0103-08 21-2120-0103-12 21-2120-0103-14 21-2120-0103-15 21-2120-0103-17 21-2120-0103-249 21-2120-0103-51 21-2120-0103-78 21-2120-0104-01 21-2120-0104-231 21-2120-0105-00 21-2120-0105-01 21-2120-0105-02L 21-2120-0105-03L 21-2120-0105-06L 21-2120-0105-07L 21-2120-0105-08 21-2120-0105-08L 21-2120-0105-12L 21-2120-0105-13L 21-2120-0105-14L 21-2120-0105-15L 21-2120-0105-17L 21-2120-0105-50 21-2120-0105-50L 21-2125-0104-01 21-2125-0105-03L 21-2125-0105-07L 21-2125-0105-08L 21-2125-0105-50L 21-2127-0104-01 21-2127-0105-01 21-2127-0105-02L 21-2127-0105-03L 21-2127-0105-06L 21-2127-0105-08L 21-2127-0105-50L

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·May 14, 2025

CADD

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 2, 2022

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 8, 2022