17 results · 31ms · Sources: EU EUDAMED, US FDA

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BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119

FDA 510(k)
FDA Class 2 ·Immunology

SCANLAN® Titanium Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159019698·TITAN MICRO FORCEPS FLAT HANDLE BAYO STYLE 1mm ...

SMITH MEDICAL

FDA Adverse Event
Injury ·SMITH MEDICAL·Product code FOZ·March 26, 2012

MICROPOBE SERIES OF LASERS AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X24.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSD·October 25, 2021

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 18, 2023

BHR

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2013

CAVICIDE

FDA Adverse Event
Injury ·METREX RESEARCH·Product code LRJ·February 24, 2011

3.5FR P.U.R. UMBIL CATH X10

FDA Adverse Event
TYCO HEALTHCARE/KENDALL·Product code FOS·February 26, 2008

SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSD·June 26, 2018

SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-21

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSD·June 11, 2018

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

FDA Enforcement
Class II ·Ongoing·GE Healthcare·April 9, 2025