21 results · 22ms · Sources: EU EUDAMED, 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