17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000400·MCK Patellofemoral Component
Cannula, Suction, acc. Bugge 29cm Ø10mm medium
FDA UDI
Geister Medizintechnik GmbH·04057034040232·Cannula, Suction, acc. Bugge
29cm Ø...
N/A
FDA UDI
Ortho Development Corporation·00822409128907·4-in-1 Cut Guide w/ Anterior Lip Size 2
SITE-RITE VISION ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2020
STN PN THD TIP .125X2.5IN 2PK
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LXH·November 13, 2019
ARROR STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 17, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 27, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 23, 2014
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·November 21, 2018