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