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

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CONMED MACROLYTE DISPERSIVE ELECTRODE

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

Bur PM2-MIS P160 diam C Ø2.0 St

FDA UDI
Bien-Air Surgery SA·17630055512168·

Oticon

FDA UDI
Oticon A/S·05707131163592·ACTO PRO, RITE STG

V.A.T.S. CLASSIC CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·B09921006860·V.A.T.S. CLASSIC CLAMP CURVED WITH RATCHET DEBA...

V.A.T.S. CLASSIC CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896003019·V.A.T.S. CLASSIC CLAMP CURVED WITH RATCHET DEBA...

REMSTAR PRO C-FLEX+

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 30, 2025

N/A

FDA UDI
Doppkon GmbH & Co. KG·04262494462320·Hook Probe Square Handle Steel D 2.5mm, WL 260mm

Monoblock Tibial Trial PS Insert

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042837·

KROM-ALGINATE AND ALGINATE PLUS

FDA 510(k)
FDA Class 2 ·Dental

KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C

FDA 510(k)
FDA Class 2 ·Cardiovascular

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 8, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·May 18, 2011

WATER FILTER

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FEB·July 27, 2022

Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·October 1, 2025

Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

Brilliance iCT - Model 728306 Computed Tomography X-ray systems

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

IVEA Product Part Number 16100 Model 500A

FDA Enforcement
Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017