17 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InMode FRF Applicator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131288080·H33V2, DESIGNRITE 10 WL MOP
Prolift Post-Pack Instruments
FDA UDI
Life Spine, Inc.·00190837031930·
Light Cure Adhesive
FDA UDI
TP ORTHODONTICS INC·00192029000106·ADHESIVE, BRACKET-Tooth Conditioner, Resin
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111134487·DISSECTING SCISSORS CVD 4 1/4"
DIVAS DUAL PLEASURE MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DYNAMIC ECG SYSTEM MODEL TLC5000
FDA 510(k)
FDA Class 2
·Cardiovascular
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. SHANGHAI·Product code INI·October 8, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·June 7, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·June 7, 2011
MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025