20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TANDA PEARL, ULTRAWYTE, PEARL
FDA 510(k)
FDA Class 1
·Dental
HEX-FIX
FDA UDI
Smith & Nephew, Inc.·03596010069566·TITANIUM HALF PIN 6.0MM X 40MM
ArgenZ HT+ 95x16 C3
FDA UDI
ARGEN CORPORATION, THE·D818122725·Dental porcelain/ceramic restoration kit
Hydrodissection Cannula, 25ga
FDA UDI
KATALYST SURGICAL LLC·00840096211023·Hydrodissection Cannula, 25ga
CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 18, 2024
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 20, 2023
AGC DA2000 KN TIB BRG 71/75X8
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 9, 2026
PHYSIOMESH
FDA Adverse Event
Injury
·ETHICON, INC·Product code FTL·May 21, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTL LTD.·Product code KWA·June 3, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
FDA Enforcement
Class II
·Terminated·Neurotherm, Inc.·April 20, 2016
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·May 13, 2025
TINBN VANGUARD INT PS ANAT FM R 75MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·June 4, 2025
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·June 4, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026