20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768482·GENUMEDI PSS GREEN IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV
Oticon
FDA UDI
Oticon A/S·05707131280718·NERA2 PRO, BTE 13 WL 100 STG
Healthweigh
FDA UDI
Rice Lake Weighing Systems, Inc.·00850042373347·Scale,Wheelchair Model RL-350-6 1000lb(450kg)x0...
Disposable Brushes
FDA UDI
TP ORTHODONTICS INC·00192029049563·Brush
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100189·MCINTYRE SPECULUM CLOSED WIRE
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028611·PESSARY, HODGE #1, W/O SUPPORT, 70mm
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·August 15, 2012
JASMINE AZ
FDA Adverse Event
Injury
·INVAMEX·Product code FSA·October 12, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
TALENT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 6, 2013
ETRIO
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·July 6, 2011
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
BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 15, 2017