31 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Navigated Spine Instruments
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114155·KRATZ POLISHER 23GA END (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113806·VISCO CANNULA 30GA ANGLE 8MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
FDA 510(k)
FDA Class 2
·Cardiovascular
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
FDA Class 3
·Cardiovascular
TRANSFX ANGLED RODS
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 8, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 24, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 19, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 2, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 16, 2018
HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code HIF·October 10, 2008
RF ENHANCR II
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LPB·August 11, 2011
CORAIL2 NON COL HO SIZE 9
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code KWA·July 2, 2013
3.5X28MM CORT LOCK SCR STE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRS·November 15, 2024
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
FDA Enforcement
Class II
·Ongoing·MicroPort Orthopedics Inc.·December 25, 2024
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
PRO-STAY 8/PK
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GDG·April 27, 2016