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