21 results · 37ms · Sources: EU EUDAMED, US FDA

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LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM

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

QUASAR

FDA UDI
Modus Medical Devices Inc·G34350036140·MRI4D - 30mm ID fillable hollow sphere tumour m...

SCANLAN®

FDA UDI
SCANLAN INTERNATIONAL INC·00846159008784·Micro Clamp

TEKNO®

FDA UDI
Tekno-Medical Optik-Chirurgie GmbH·04044684023029·OLSEN-HEGAR NEEDLE HOLDER 14CM

Harvest Nano Zirconia

FDA UDI
Harvest Dental Products, LLC·D87060036141·Harvest Nano Zirconia ColorBlend OM2 98.5 x 14

QUASAR

FDA UDI
Modus Medical Devices Inc·G34350036140320·MRI4D - 32mm Solid Acrylic sphere tumour model ...

QUASAR

FDA UDI
Modus Medical Devices Inc·G34350036140200·MRI4D - 20mm ID fillable hollow sphere tumour m...

QUASAR

FDA UDI
Modus Medical Devices Inc·G34350036140100·MRI4D - 10mm ID fillable hollow sphere tumour m...

STRYKER TRAUMA PELVIC SET

FDA 510(k)
FDA Class 2 ·Orthopedic

ADVENT IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·August 28, 2025

EQUINOXE REVERSE SHOULDER COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·September 25, 2024

MAHURKAR 13.5FR X 13.5CM PC KIT

FDA Adverse Event
Malfunction ·COVIDIEN·Product code MSD·February 12, 2013

SHAMPAINE OPERATING ROOM TABLE

FDA Adverse Event
Injury ·GETINGE - CASTLE USA, INC·Product code FQO·February 18, 2011

EMBRACE PUMP

FDA Adverse Event
Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·February 20, 2008

LIGHTSHEER EC

FDA Adverse Event
Injury ·RH USA, INC.·Product code GEX·August 28, 2012

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Enforcement
Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024