21 results · 22ms · Sources: EU EUDAMED, US FDA

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ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

2.5mm Hex Driver Sleeve

FDA UDI
Osteocentric Technologies, Inc.·00816950028571·2.5mm Hex Driver Sleeve

NA

FDA UDI
Smith & Nephew, Inc.·00885556006931·HIBBS LAMINECTOMY RETRACTOR SINGLE END

Ormco

FDA UDI
ORMCO CORPORATION·00889989028478·SS BROAD ARCH LO SML 0160X0220 PK/10

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

FDA Enforcement
Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

ULMER PHARMACAL CO.

FDA registration
ULMER PHARMACAL CO.·1 product·🇺🇸 United States

Matira

FDA UDI
Kalitec Direct LLC·B07307K1100010·Tray Insert 1, Matira, Arcamed

ALEUTIAN® Interbody Systems

FDA UDI
VB Spine LLC·10888857527959·Inserter, Outer Shaft/Handle

MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Dental

SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·May 13, 2022

OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·INSULET CORPORATION·Product code QFG·May 2, 2024

QUATTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 1, 2011

BD INSULIN PEN NEEDLE

FDA Adverse Event
Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 8, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 6, 2019

PERCEPT

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 14, 2024

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 26, 2021