21 results · 24ms · Sources: EU EUDAMED, 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