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

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SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

MONARCH SPINAL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

HIGH FLOW INSUFFLATION UNIT UHI-4

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 10, 2020

12/14 ARTICUL 40MM M SPEC+1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 2, 2014

PINNACLE MTL INS NEUT40IDX56OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 2, 2014

EON MINI

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 3, 2013

OCTRODE

FDA Adverse Event
Injury ·ST.JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 17, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2011

AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JDI·January 8, 2014

4.5 BROAD SCP PLT 26-H STER

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

PINNACLE MTL INS NEUT40IDX56OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·April 27, 2012

ASPHERE M SPEC 12/14 40 +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 27, 2012

PINN SECTOR W/GRIPTION 56MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 2, 2014

ACCOLADE DR EL MRI (Model L331)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025