12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cefaly Acute
FDA 510(k)
FDA Class 2
·Neurology
Ambler Value Line
FDA UDI
AMBLER SURGICAL CORP.·00190660214227·Deaver retractor, 12'' long x 3'' wide blade, f...
ELECTRODE ARRAY CAP
FDA 510(k)
FDA Class 2
·Neurology
EMERALD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151986·17 X 14 CERVICAL TRIALS 46MM 0° LORDOSIS
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606152174·17 X 14 CERVICAL TRIALS 46MM 10° LORDOSIS
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-SWITZERLAND·Product code NKB·October 14, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·June 30, 2011
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·March 17, 2026
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