15 results · 21ms · Sources: EU EUDAMED, US FDA

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DEPUY C-STEM SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GE

FDA UDI
Conmed Corporation·10653405002611·ECG LEADWIRES

BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ONTRAK TESTCUP 501, MODEL 3016633

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

PERSONA FEMUR CEMENTED POSTERIOR STABILIZED

FDA Adverse Event
Injury ·ZIMMER ORTHOPAEDIC MFG. LTD.·Product code JWH·November 21, 2019

NONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·February 28, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2011

CATH PKGD: BERMAN 5 FR 8 0CM

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DQO·February 21, 2008

LANTERN DELIVERY MICROCATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code DQY·July 24, 2023

BD BBL¿ TAXO¿ A DISCS FOR DIFFERENTIATION OF GROUP A STREPTOCOCCI

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code JTO·June 19, 2023

DREAMSTATION AUTO CPAP

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·January 6, 2022

1.5 MM SYSTEM 4-HOLE EXTRA LONG STRAIGHT PLATE

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·July 13, 2016

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018