21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InMode RF System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197077996·Deaver Retractor
38x300...
SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OUR·October 8, 2019
PTS PANELS CHOL+HDL PANEL TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASR ACETABULAR IMPLANT 66
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·October 14, 2014
PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·June 15, 2013
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 21, 2011
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·October 8, 2020
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·June 15, 2021
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FCG·December 26, 2017
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·Product code DQX·October 28, 2021
LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·February 1, 2022
SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OUR·February 5, 2021
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Death
·WILLIAM COOK EUROPE·Product code DQX·March 23, 2022
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·September 17, 2019
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·September 17, 2019
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·December 4, 2019
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Death
·WILLIAM COOK EUROPE·Product code DQX·July 18, 2019
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