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

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Straumann Variobase Abutments

FDA 510(k)
FDA Class 2 ·Dental

Oticon

FDA UDI
Oticon A/S·05707131318848·OPN 3, MRITE 312 2.4G NFM PB C068

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613084837·K-Wire, Double Ended, Trocar Point, Diameter 0....

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776385163·HANK DILATOR 5/6 FR

MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM

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

TDS PRECISION DENTAL BAR

FDA 510(k)
FDA Class 2 ·Dental

ACCU-CHEK SPIRIT ADAPTER

FDA Adverse Event
Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 17, 2010

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 20, 2011

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code PAH·June 14, 2013

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 12, 2008

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

(17-0356) ANK IMPL B 14 D 4.5 MM/L 14 MM

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·March 13, 2021

(17-0356) ANK IMPL B 14 D 4.5 MM/L 14 MM(IMPLANTS)

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 17, 2021