15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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