33 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPAL BOND FLOW
FDA 510(k)
FDA Class 2
·Dental
Bur PM2-70 50K Steel Ø5.0
FDA UDI
Bien-Air Surgery SA·07630055502742·
Dynamic Axial Fixator
FDA UDI
ORTHOFIX SRL·18032568031911·DRILL BIT DIAMETER 3.2 MM LENGTH 200 MM
OsteoMed
FDA UDI
OSTEOMED LLC·00845694001885·5mm Pyriform Rigid Plate
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989026986·TMA BROAD ARCH ROUND16 UP SML PK/10
SPENCER SUTURE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047211·SPENCER SUTURE SCISSORS NORTH BENT ANGLED BLADE
RELiZORB (100300/ 100301)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RELiZORB (100300/100301)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dynamic Axial Fixator
FDA UDI
ORTHOFIX SRL·18033509856075·DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK ...
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604895·MOSS 100 Locking Cap Driver
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063333·2OS 5mm Pyriform Rigid Plate Sterile Qty 5
IMMUNOWELL EA (D) IGG TEST
FDA 510(k)
FDA Class 1
·Microbiology
MOBIVISION
FDA 510(k)
FDA Class 2
·Radiology
JTS (JUVENILE TUMOR SYSTEM)
FDA Adverse Event
Malfunction
·ONKOS SURGICAL·Product code KRO·January 29, 2026
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 21, 2011
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 1, 2011
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·May 8, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 18, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 24, 2011
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501.
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007