14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire
FDA UDI
Promepla·03700512967477·
EndoPilot contra-angle
FDA UDI
Schlumbohm GmbH & Co. KG·04260482990091·EndoPilot contra-angle
for apexlocation
full is...
exsalt CMC Gelling Fiber Dressing
FDA UDI
Exciton Technologies Inc·07540127000314·exsalt™ CMC Gelling Fiber Dressing is a soft, s...
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
FDA 510(k)
FDA Class 2
·Cardiovascular
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HSB·March 3, 2025
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 19, 2013
BO-TOP 23102 SCOTT & WHITE OR CPB PACK
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DWF·August 18, 2014
SCORPIO FEMORAL COMPONENT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·May 5, 2011
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014