15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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