21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05707131280756·NERA2 PRO, BTE 13 WL 100 TC
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100189·MCINTYRE SPECULUM CLOSED WIRE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100028·BLUMENTHAL SPECULUM X-HEAVY
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028659·PESSARY, HODGE #5, W/O SUPPORT, 90mm
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020218·Posterior Stabilized Tibial Insert
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000
FDA 510(k)
FDA Class 1
·Physical Medicine
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
MISAGO RX Self Expanding Peripheral Stem
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 7, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 6, 2013
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 6, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 8, 2019
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 6, 2019