17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEART™
FDA UDI
SUNMED, LLC·10889483222324·HEART™ Continuous Nebulizer, Adult Aerosol Mask...
Heart® Continuous Nebulizer Adult Kit,10cc Syringe
FDA UDI
WESTMED, INC.·00709078000065·Heart® Continuous Nebulizer Adult Kit,10cc Syringe
ENDOGATOR Kit
FDA UDI
MEDIVATORS INC.·00677964056932·
MOVES
FDA UDI
Thornhill Research Inc·10807141000152·MOVES Clamps
DEBAKEY COARCTATION CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921006260·DEBAKEY COARCTATION CLAMP STRAIGHT JAW CURVED S...
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494461767·Endoscopic Kerrison Punch
D 3.0mm, 40°, WL 200mm
Monoblock Tibial Trial PS Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042417·
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 15, 2022
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 8, 2013
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·May 13, 2011
UNKNOWN
FDA Adverse Event
Injury
·Product code FWM·August 6, 2008
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·September 12, 2012
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020