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

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EDEN Spinal Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

DJO SURGICAL

FDA UDI
Encore Medical, L.P.·00190446885900·SPECIAL, RSP CENTRAL DRILL GUIDE, 0°, 2.4 K WIR...

HHM

FDA UDI
Oticon A/S·05707131355201·G300 SC, MINIRITE 312 2.4G C047 HHM

NA

FDA UDI
Synthes GmbH·10886982142870·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

Lotion/Gel Warmer

FDA UDI
COMPASS HEALTH BRANDS CORP.·00853904006087·Gray 3 Bottle Warmer (120V)

Symmetry Kleinert-Kutz

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482039342·Symmetry® Elevator, Kleinert-Kutz, Sharp, & Dis...

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF2017880·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...

ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200

FDA 510(k)
FDA Class 2 ·Cardiovascular

NBD CEMENT RESTRICTOR DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SYMPHONY

FDA Adverse Event
Injury ·SORIN CRM·Product code NVZ·July 12, 2017

GORE EXCLUDER AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES·Product code MIH·October 15, 2008

SCREW-IN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·January 12, 2017

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·January 18, 2017

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·March 14, 2023

GORE DUALMESH PLUS BIOMATERIAL

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code FTL·February 26, 2019

IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·January 11, 2018

DAVINCI XI

FDA Adverse Event
Injury ·INTUITIVE SURGICAL, INC·Product code NAY·May 31, 2022