14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dark Star Deformity Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED VESSEL SEALER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·November 15, 2021
BD BBL¿ SABOURAUD AGAR WITH CHLORAMPHENICOL
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·November 9, 2021
LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 28, 2012
PLATE SABOURAUD AGAR W/CHMP 90MM 20
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·November 7, 2021
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·November 4, 2014
VENTILATOR, CONTINUOUS, FACILITY USE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·August 10, 2011
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·July 12, 2013
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018