22 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040016824·CHANNELS MTA CEMENT SAMPL EA
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717103711·Stainless Steel K Files (Hand), Size # 08, Leng...
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
FDA 510(k)
FDA Class 2
·Immunology
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT
FDA 510(k)
FDA Class 2
·Ophthalmic
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
NANOKNIFE SYSTEM
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code OAB·June 9, 2015
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
XENIUM 150 SYNTH HF DIALYZERSYNTHETIC FOR HEMODIALYSIS
FDA Adverse Event
Injury
·NIPRO CORPORATION USD·Product code KDI·March 16, 2011
MULTIGAS MONITOR
FDA Adverse Event
Death
·MEDRAD, INC.·Product code CCK·March 28, 2008
RP 360 DEGREE SUTURE PASSER NEEDLE, BOX OF 5
FDA Adverse Event
Malfunction
·CROSSTEK MED·Product code MDM·June 9, 2015
RP 360 DEGREE SUTURE PASSER NEEDLE, BOX OF 5
FDA Adverse Event
Malfunction
·COORSTEK MEDICAL·Product code MDM·June 9, 2015
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024