21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERIMETER INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
RC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600381341·
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277100917·Cannestra Hip Length Gauge Set with Case
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027537·
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
FDA 510(k)
FDA Class 2
·Orthopedic
THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·June 19, 2017
THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·June 22, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
CARTO® 3 SYSTEM INTERFACE CABLE
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DQK·October 31, 2012
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·May 29, 2013
JUVEDERM VOLUMA XC 27G 2 X 1ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·September 29, 2014
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
STRYKER MEDICAL·Product code FPO·June 8, 2011
LASSO® 2515 NAV ECO VARIABLE CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·August 9, 2013
THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER INC.·Product code LPB·June 6, 2019
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC.·Product code LPB·May 24, 2018
WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code DRF·November 1, 2016
SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FSM·July 9, 2018
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·October 31, 2012
VERSAFITCUP CC TRIO ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 10, 2026