19 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Vitalograph Model 6300 micro

FDA 510(k)
FDA Class 2 ·Anesthesiology

Monza Cervical Plate System

FDA UDI
Altus Spine, LLC·B41711602531·53mm Cervical Plate, 2 Level

Denovo general purpose dental molar band

FDA UDI
Denovo Dental, Inc.·00810059290464·Denovo general purpose dental molar band - Mand...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197416818·Nervehook LOEPRECHT 3 mm diam. 150 mm...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197416795·Nervehook LOEPRECHT 2 mm diam. 150 mm...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197416801·Nervehook LOEPRECHT 2.5mm diam. 150 mm...

VISUMAX LASER KERATOME

FDA 510(k)
FDA Class 2 ·Ophthalmic

STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.

FDA 510(k)
FDA Class 2 ·Orthopedic

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 21, 2023

GORE DRYSEAL FLEX INTRODUCER SHEATH

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020

AMISTEM H, HA COATED STEM SIZE 4 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 27, 2017

GORE® DRYSEAL FLEX INTRODUCER SHEATH

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016

DOUBLE MOBILITY HC LINER 28/DMG

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·March 30, 2017

CAUTERY HOOK TIP

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2013

HS III PROXIMAL SEAL SYSTEM 4.3MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·June 2, 2011

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

GORE® DRYSEAL FLEX INTRODUCER SHEATH

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 30, 2023

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025