21 results · 28ms · Sources: EU EUDAMED, US FDA

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AccelFix Spinal Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

A.R.T.™FEMORAL NAIL

FDA UDI
Biomet Orthopedics, LLC·00887868005541·

Cutimed® Sorbact®

FDA UDI
BSN medical GmbH·07392130002263·CUTIMED SORBACT GEL STERILE 8"X10" GREEN 5 US

Needle Holder

FDA UDI
KATENA PRODUCTS, INC.·00841668108109·JAFFE NEEDLE HOLDER CURVED

XiVE®

FDA UDI
Dentsply Implants Manufacturing GmbH·07392532223440·Twist Drill crestal D3.4

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197477413·Whitehead mouth gag 130mm, 5"

NA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295149255·CORE CASE 1 INSTRUMENT CASE COMPLETE

ResolutionMD

FDA 510(k)
FDA Class 2 ·Radiology

ACUSON Juniper Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·October 9, 2024

MERIT HEMOSTASIS VALVE

FDA Adverse Event
Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DQX·August 25, 2011

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 19, 2014

UNKNOWN DEPUY ASR FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·September 23, 2011

HT70 VENTILATOR

FDA Adverse Event
Injury ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·July 31, 2013

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

XP-XP Tibial Tray - Interlok 63 mm Item # 195751

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026