12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JuggerKnot Soft Anchor OC
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Medos International Sàrl·10886705011230·ACORN REAMER, STERILE 20 - 130mm (Plus or Minus...
RR - UP - Commuter Passenger - zlb
FDA UDI
Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102909·JAFFE-BECHERT MANIPULATOR ANG SHORT HNDL
TP Original Wire
FDA UDI
TP ORTHODONTICS INC·00192029028896·Standard Plus Round
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
AFFIX II SPINOUS PROCESS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
BATTERY 14.8V, 6.3 AH LI-LON BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 17, 2014
CBC III-(3/16" KIT) PKG/6 WORLD
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·August 26, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025