22 results · 27ms · Sources: EU EUDAMED, US FDA

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PARE ENDOSCOPIC SUTURING SYSTEM

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

MPS 3 Delivery Set w/AA w/305cm Line

FDA UDI
QUEST MEDICAL INC·00634624531024·

MPS 3 Mini Prime Delivery Set w/AA w/o Line

FDA UDI
QUEST MEDICAL INC·00634624731028·

Laminated Bite Wafers-Wax

FDA UDI
Denplus Inc·D8453003102·Laminated Bite Wafers-Wax, White, 35 units

PVA (Zn) Fix/10% Formalin 25 sets

FDA UDI
Alpha-TEC Systems, Inc.·00816085022314·PVA (Zn) Fix/10% Formalin 25 sets

MPS 3 Delivery Set w/AA w/183 Line (10C)

FDA UDI
QUEST MEDICAL INC·00634624500327·

BOTANIQ

FDA UDI
Inspecs U.S.A., L.C.·00841543148411·SUNGLASS

INJECTOR LUER LOCK N35C MULTIPACK

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·February 10, 2021

Diamondback Peripheral

FDA UDI
Cardiovascular Systems, Inc.·10852528005930·Diamondback Peripheral, Exchangeable Series, Ca...

VITROS IMMUNODIAGNOSTIC PRODUCTS SIGNAL REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code PPM·January 8, 2026

PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E

FDA 510(k)
FDA Class 2 ·General Hospital

GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HWC·March 13, 2013

BD INSYTE AUTOGUARD SHIELDED IV CATHETER

FDA Adverse Event
Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·February 3, 2011

IMPLANTIUM

FDA Adverse Event
Other ·DENTIUM CO., LTD.·Product code DZE·February 22, 2008

VERCISE GENUS?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·February 6, 2026

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·December 20, 2019

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Enforcement
Class II ·Terminated·Natus Medical Incorporated·December 21, 2016