18 results · 21ms · Sources: EU EUDAMED, US FDA

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HOLY DRAGON ACUPUNCTURE NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

Scope Buddy Plus Tubing

FDA UDI
MEDIVATORS INC.·40677964021976·24 Hour Tubing for FUJIFILM 700 Endoscopes

Reef TH

FDA UDI
Seaspine Orthopedics Corporation·10889981212865·Trial 9w, 10mm

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450285930·

XIPHOS ZFUZE

FDA UDI
Difusion Technologies, Inc.·00853896008168·PLIF Spacer 29mm Long x 10mm Height

DYNATECH SPD 2000, NUMBER 002-910-0000

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AMISTEM C CEMENTED STD STEM SIZE 3

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2022

STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

IM-9C MICROINJECTORS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 7, 2025

VUELOCK PLATE, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

DEPUY ASR XL FEM IMP SIZE 43

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·March 13, 2013

ASR UNI FEMORAL IMPL SIZE 45

FDA Adverse Event
Injury ·DEPUY INT'L LTD·Product code KWA·February 16, 2011

IMPLANTIUM

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

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

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024