33 results · 25ms · Sources: EU EUDAMED, 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