123 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3.0 Dynamic TiBase
FDA 510(k)
FDA Class 2
·Dental
CASPAR RETRACTOR FRAME
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896037021·CASPAR RETRACTOR FRAME ROTATBLE ARMS CERVIC VER...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776116231·Keyhole Bracket
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776020330·Keyhole Bracket
Straight Trocar Pin with Shoulder 3.2x90
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215061951·
CRYO-TOUCH II
FDA 510(k)
FDA Class 2
·Neurology
KOWA VX-10I
FDA 510(k)
FDA Class 2
·Ophthalmic
NA
FDA UDI
Zimmer, Inc.·00889024084926·
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·July 24, 2023
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code GEX·August 25, 2021
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 3, 2013
VASOVIEW 6 EVH SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 11, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 2014
PEDICLE SCREW LATERAL CONNECTOR L150
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023
Cub 2 Enclosed Bed Canopy System
FDA Enforcement
Class I
·Ongoing·Sensory Medical Inc·April 20, 2022
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
FDA Enforcement
Class III
·Ongoing·Howmedica Osteonics Corp.·December 28, 2022
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
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
FDA Enforcement
Class II
·Terminated·Galt Medical Corporation·December 23, 2020
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
FDA Enforcement
Class III
·Ongoing·Boston Scientific Corporation·January 16, 2019