24 results · 22ms · Sources: EU EUDAMED, US FDA

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BIOTEQ Drainage Catheter Set (One Step Type)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Tether

FDA UDI
Seaspine Orthopedics Corporation·10889981101619·Var. Angle Corner Guide/Holder

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR32001031·Distance ring 3 mm f. mand. protrusion appliance

DEBAKEY TISSUE FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059795·DEBAKEY TISSUE FORCEPS FLAT HANDLE

OsteoMed

FDA UDI
OSTEOMED LLC·00845694006132·1.6mm Pilot Drill, 16mm, Dental Latch

Lapiplasty SpeedPlate

FDA UDI
Treace Medical Concepts, Inc.·00810111221740·Inserter Cap

OsteoMed

FDA UDI
OSTEOMED LLC·00845694010979·Screw Length Gauge

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869608244·TELIX K Hammer

AVL OPTI R ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PRISMAFLO

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENDOSKELETON¿ TAS INTERBODY SYSTEM

FDA Adverse Event
Malfunction ·TITAN SPINE, A DIVISION OF MEDTRONIC·Product code HWJ·September 3, 2025

SMR REVERSE HUMERAL BODY SHORT

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A·Product code PHX·January 11, 2024

BONE SCREW 6,5 H.30MM

FDA Adverse Event
Injury ·LIMA CORPORATE S.P.A.·Product code LPH·February 7, 2020

MANUAL FILL INFANT HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·October 15, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013

ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with Anspach Systems

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System

FDA Enforcement
Class II ·Completed·Boston Scientific Corporation·May 6, 2020