24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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