31 results · 24ms · Sources: EU EUDAMED, 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