16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LED TURBO
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
MEDTRONIC, INC.·20643169739578·ACCESS 040618 ADHESV DISK PAT LBL UPDATE
NA
FDA UDI
MEDTRONIC, INC.·20613994518853·ACCESS 040618 ANTENNA TAPE PATCH GLOBAL
N/A
FDA UDI
MEDTRONIC, INC.·20763000404264·ACCESS 040618 ADHESIVE DISC PAPER LC69
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742110646·LYNX ø3.5mm Std Cortical Screw, Full Thread, Se...
PALOMAR DERMALUX PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code BSP·November 21, 2019
TESS GLENOID REVERSE HEAD DIAMETER 36
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2018
STERRAD 200, SINGLE DOOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·April 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 27, 2014
ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 5, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018