19 results · 22ms · Sources: EU EUDAMED, 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