11 results
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19ms
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Sources: EU EUDAMED, US FDA
PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Bosworth Trim II
FDA UDI
Harry J Bosworth Company·H66809210951·1-1/2 oz PEMA Pwd # 65 (D3)
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869657372·MOSS XT Ti Pedicle Screw Ø10.0x95mm grey, cannu...
DX-D IMAGING PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 17, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024