17 results · 23ms · Sources: EU EUDAMED, US FDA

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Revitalair 430+

FDA 510(k)
FDA Class 2 ·Anesthesiology

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540356659·SCREWDRIVER RATCHETING HANDLE

TOSHIBA 1.5T CARDIAC COIL

FDA 510(k)
FDA Class 2 ·Radiology

DASH 3000/4000 PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

1220290-1999-00002

FDA Adverse Event
Injury ·Product code HQC·September 29, 1999

T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·May 2, 2018

AUTOSOFT 90

FDA Adverse Event
Malfunction ·Product code FPA·July 10, 2020

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·October 1, 2019

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 11, 2022

ILET BIONIC PANCREAS

FDA Adverse Event
Malfunction ·BETA BIONICS INC.·Product code QFG·January 6, 2026

RANAWAT/BURSTEIN ACETABULAR SHELL 54MM POROUS COATED

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·August 26, 2016

SOFTCLIX PLUS LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·November 3, 2008

GENDER SOLUTIONS NATURAL KNEE ART SURFACE

FDA Adverse Event
Injury ·ZIMMER INC·Product code JWH·August 16, 2011

RIATA ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P

FDA Adverse Event
Malfunction ·STRYKER LEIBINGER FREIBURG·Product code DZL·September 4, 2018

MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P

FDA Adverse Event
Malfunction ·STRYKER LEIBINGER FREIBURG·Product code DZL·January 22, 2019

Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018