26 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
FDA 510(k)
FDA Class 2
·Orthopedic
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950018505·FORCEP TISSUE #34 SEMKIN TAYLOR 1X2 TEETH CVD 5...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002141·artVeneer life lower posteriors, XL, D3
CURE OPEL-L (S)
FDA UDI
MEDITECH SPINE, LLC·B167900021410·
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918183879·Pacemaker with lateral triangle fenestration_24...
CURE OPEL-L (S)
FDA UDI
MEDITECH SPINE, LLC·B167S1900021410·
Fiber Cable Assembly
FDA UDI
Candela Corporation·00817495022468·Fiber Assembly
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
POWDER FREE STERILE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CERTAIN® TITANIUM HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·May 10, 2017
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013
PINN MULTIHOLE W/GRIPTION 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 18, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·February 25, 2008
VELOCITY DELIVERY MICROCATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·May 31, 2024
LL-CO2 CRYOSURGICAL SYS
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·July 22, 2022
OXF TWIN-PEG CMNTD FEM LG PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·May 21, 2021
UNK OXFORD FEMORAL COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 6, 2020
POD COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·June 25, 2025
OXF ANAT BRG RT LG SIZE 4 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·May 21, 2021
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023