19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HYALURONIDASE REAGENT, MODEL CAT#2212
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092123478·Multi-Unit Titanium Screw (.050 Hex)
Implant Prosthetics
FDA UDI
Preat Corporation·00842092165287·Multi-Unit Titanium Screw (.050 Hex)
Implant Prosthetics
FDA UDI
Preat Corporation·00842092117118·Multi-Unit Titanium Screw (.050 Hex)
Implant Prosthetics
FDA UDI
Preat Corporation·00842092122105·Multi-Unit Titanium Screw (.050 Hex) (10-Pack)
Implant Prosthetics
FDA UDI
Preat Corporation·00842092123485·Multi-Unit Titanium Screw (.050 Hex) (10-Pack)
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 12, 2026
MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
RHIGENE MESACUP2 TEST- SSB
FDA 510(k)
FDA Class 2
·Immunology
ALLOFT-S ALLOCLASSIC SHL 52/II
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code JDI·March 12, 2019
FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LWS·March 12, 2013
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURUING·Product code LKK·February 24, 2011
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DSI·February 22, 2008
ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 27, 2018
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 21, 2019
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024