25 results · 22ms · Sources: EU EUDAMED, US FDA

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Tryptik Ti

FDA 510(k)
FDA Class 2 ·Orthopedic

Lapidus Trial

FDA UDI
Treace Medical Concepts, Inc.·00810111224086·TMC Lapidus Trial, 9mm

OsteoMed

FDA UDI
OSTEOMED LLC·00845694006484·1.6mm Pilot Drill, 6mm Stop, Osteopower

OsteoMed

FDA UDI
OSTEOMED LLC·00845694011044·1.8mm Pilot Drill, OSTEOPOWER

ELMED

FDA UDI
ELMED INCORPORATED·00842180171336·2MM DIA., 150MM (6") VERESS INSUFLATION NEEDLE

VARELISA SM ANTIBODIES

FDA 510(k)
FDA Class 2 ·Immunology

ULTIMA SNORING MIKE, MODEL 0540

FDA 510(k)
FDA Class 2 ·Anesthesiology

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 22, 2020

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 19, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 19, 2023

BIOLOX DELTA HEAD

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A·Product code LZO·December 12, 2025

CONSULTA CRT-D

FDA Adverse Event
Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 13, 2013

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 25, 2020

FLEXICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 11, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 1, 2013

I-STAT TROPONIN (HS-TNI ) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·April 1, 2026

Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

FDA Enforcement
Class II ·Terminated·Philips Healthcare Inc.·September 26, 2012

HUMAPEN ERGO, BURGUNDY CLEAR

FDA Adverse Event
Malfunction ·ELI LILLY AND COMPANY·Product code FMF·July 30, 2015

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·August 1, 2022