14 results
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21ms
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Sources: EU EUDAMED, US FDA
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
FDA 510(k)
FDA Class 2
·Anesthesiology
Shannon Recta Corta Round Shank
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613289594·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606804·GETINGE / SHAMPAINE 4900/5100B, 5100E 3" STANDARD
Cordera Hip System (Stainless Steel) Trial Neck 132degree,29.0mm
FDA UDI
Conformis, Inc.·00810933031152·(Stainless Steel) Trial Neck 132degree,29.0mm
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 26, 2013
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 22, 2008
ECHELON
FDA Adverse Event
Injury
·HITACHI MEDICAL CORP.·Product code LNH·April 26, 2011
COPELAND THN SHL COCR/HA HUMS3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·August 28, 2025
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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