15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELMED
FDA UDI
ELMED INCORPORATED·00842180150157·5mm,34cm, Retractor/Elevator with 5 Flat Blades...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197441063·Micro Spatula Dissector
narrow...
NARROW STANDARD LARGE HEXED DRIVER, 24MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NDP·October 23, 2023
Freedom Spinal Cord Stimulator System
FDA 510(k)
FDA Class 2
·Neurology
JSZ-MULTIPURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 20, 2012
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 16, 2011
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·July 26, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 17, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024