12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PACSEAL PIT & FISSURE SEALANT
FDA 510(k)
FDA Class 2
·Dental
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304232693·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613021498·Brackman Suction Tube, 7Fr, Offset Suction Tip ...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613062057·Brackman Suction Tube, 3Fr
K2M General Instruments
FDA UDI
VB Spine LLC·10888857583238·Modular Trial 22x8x22mm, 7°
DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING
FDA 510(k)
FDA Class 1
·Dental
POWERSTICK MALE LATEX CONDOMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·June 27, 2011
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·November 10, 2021