23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
FDA 510(k)
FDA Class 2
·General Hospital
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105640·PowerChem Neoprene Exam Gloves, Large
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964012783·The ENDO CARRY-ON Procedure Kit contains all of...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810014441·All-Gauze Sponge Non Sterile
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001444·artVeneer life upper anteriors, IM, D2
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 23, 2025
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 23, 2026
VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER DIAM 32 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 25, 2021
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·December 11, 2025
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
EDWARDS MC3 TRICUSPID ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·February 25, 2011
3M LOBAN 2 ANTIMICROBIAL DRAPE
FDA Adverse Event
Other
·3M HEALTH CARE·Product code KKX·February 14, 2008
G7 OSSEOTI MULTIHOLE 46MM B
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 7, 2023
BONE SCR 6.5X25 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 7, 2023
BONE SCR 6.5X25 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 7, 2023
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
FDA Enforcement
Class II
·Terminated·Oxus America, Inc.·February 13, 2013
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022