19 results · 20ms · Sources: EU EUDAMED, US FDA

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PIEZO BONE SURGERY

FDA 510(k)
FDA Class 2 ·Dental

DD tempMED

FDA UDI
Dental Direkt GmbH·EDDIK111201·DD tempMED are pre-colored dental milling blank...

PROGNOST ES, MODEL 0302 0000

FDA 510(k)
FDA Class 2 ·Radiology

EXETER HIP STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INSULIN PUMP

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code LZG·December 2, 2016

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code LZG·December 2, 2016

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 2, 2019

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 16, 2016

T:SLIM X2 INSULIN PUMP

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code LZG·December 8, 2016

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code LZG·December 23, 2015

UNKNOWN DEPUY ACETABULAR LINER

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 14, 2013

SROM KNEE FEM SLEEVE POR 40MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·September 23, 2014

STRETCHER

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·May 18, 2011

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 8, 2022

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·August 12, 2016

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025