22 results
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26ms
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Sources: EU EUDAMED, US FDA
GUIDELINER V2 CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...
16PW - PCI Construction - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588120829·16PW - PCI Construction - Poly White
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089404001·
ALIF Disc Prep
FDA UDI
Life Spine, Inc.·00190837079963·
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231120820·Girard Corneoscleral Forceps, w/Platform, left ...
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTIBOND SOLO PLUS ACTIVATOR
FDA 510(k)
FDA Class 2
·Dental
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242340·Torque Limiting Handle Size 30 in-lbs (3.4 N-m)...
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873098613·3.5mm Locking Superior Clavicle Plate, 7 Holes,...
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 18, 2015
GMK TIBIAL INSERT UC FIXED #2/12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 15, 2015
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON - BELGIUM/ S.A. ALCON - COUVREUR N.V.·Product code KYG·May 7, 2013
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·August 6, 2008
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 2, 2011
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021