27 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Dark Star Navigation Instrument System
FDA 510(k)
FDA Class 2
·Neurology
MEGA5.5 SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809228125814·Rod, Ø5.5 x 280mm
Spex
FDA UDI
SPEX LIMITED·09420051700925·Spex 2 Point Padded Hip Belt, Centre Pull, Cent...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197537339·Hibbs Osteotom straight 28mm 240mm
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
FDA 510(k)
FDA Unclassified
·Unknown
BD ALARIS PRIMARY PUMP INFUSION SET PVC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 22, 2026
DLP
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DWF·December 3, 2025
BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·November 4, 2025
PICC-NATE 1.9 FR
FDA Adverse Event
Injury
·UTAH MEDICAL·Product code LJS·October 24, 2008
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SMALL
FDA Adverse Event
Injury
·BIOMET UK LTD·Product code NRA·August 15, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·July 8, 2013
BD TEXIUM NEEDLE-FREE SYRINGE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·November 3, 2025
JGRKNT 1.0MM MINI 3-0 NDLS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code DZL·February 2, 2026
BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·November 4, 2025
JUGGERSTITCH CURVED IMPLANT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·June 20, 2023
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 16, 2020
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 20, 2025
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
GELPOINT® MINI ADVANCED ACCESS PLATFORM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·September 29, 2025