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