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

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SUDOSCAN

FDA 510(k)
FDA Class 2 ·Neurology

Telemetry 3 Lead Patient Cable

FDA UDI
SCOTTCARE CORPORATION, THE·00856298006077·Cardiac Rehab 3 Lead patient cable used to conn...

BABY METZENBAUM SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896090484·BABY METZENBAUM SCISSORS STRAIGHT BLADE

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776369163·Ferguson Operating Scissors, angled on flat, bl...

LEONE SPA

FDA UDI
LEONE SPA·08033707092872·BKT 33 F1000 SELF-LIGATING 22 T-11A+7BH

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780178699·Integra® Jarit® Ferguson Abdominal Scissors, 7-...

Indus®

FDA UDI
SPINEFRONTIER, INC.·00190361001065·Invue Max, Single Level ACP, 33mm

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197539593·Love Gruenwald Laminectomy Ronguer stra ight, ...

MENICON SF-P

FDA 510(k)
FDA Class 2 ·Ophthalmic

POWDER FREE NITRILE EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 31, 2022

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·April 3, 2020

ATTUNE FB TIB BASE SZ 7 CEM

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code JWH·August 6, 2019

TRULIANT TIB IMP PS INSERT SZ 3.5 11MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·May 5, 2023

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013

PRECISION SPECTRA®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 18, 2014

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·May 16, 2011

DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244

FDA Adverse Event
Injury ·FIAB SPA·Product code GEI·October 12, 2023

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

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