32 results · 20ms · Sources: EU EUDAMED, US FDA

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deepLive

FDA 510(k)
FDA Class 2 ·Radiology

Bernafon

FDA UDI
Sbo Hearing A/S·05714464056668·BERNAFON ALPHA 3 MNR T MAC

Orfit Industries

FDA UDI
Orfit Industries NV·05420028705278·10 (pcs.) Bags for Thermofit 32392

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319745281·Wylie Deep Pelvic Retractor, hollow handle, 10"...

devemed

FDA UDI
devemed GmbH·04061644017218·Caliper "Castroviejo" | 9 cm straight / 0-15 mm

ESMARCH HEAVY BANDAGE SHEARS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026865·ESMARCH HEAVY BANDAGE SHEARS

Reicodent

FDA UDI
devemed GmbH·04061644052431·Caliper "Castroviejo" | 9 cm straight / 0-15 mm

NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)

FDA 510(k)
FDA Class 1 ·General Hospital

VERSA-DIAL HUMERAL HEAD

FDA 510(k)
FDA Class 2 ·Orthopedic

TESS GLENOID REVERSE HEAD DIAMETER 36

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 10, 2014

TWIST DRILL FOR 1.5MMX 4MM SCW

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm

FDA Enforcement
Class II ·Ongoing·MICROVENTION INC.·May 20, 2026

Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

FDA Enforcement
Class I ·Ongoing·Percussionaire Corporation·October 9, 2024

Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

FDA Enforcement
Class I ·Ongoing·Percussionaire Corporation·October 9, 2024

Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

FDA Enforcement
Class I ·Ongoing·Percussionaire Corporation·October 22, 2025

3mensio Workstation (Vascular Fenestrated) software

FDA Enforcement
Class II ·Ongoing·PIE Medical Imaging B.V.·August 20, 2025

BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020