16 results · 20ms · Sources: EU EUDAMED, US FDA

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Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)

FDA 510(k)
FDA Class 1 ·Dental

BLUEENDO

FDA UDI
TROKAMED GmbH·04251303811435·Grip Module V2.0, 5-times-use for Morcellator S...

GRANDIO FLOW

FDA 510(k)
FDA Class 2 ·Dental

ANDON BLOOD PRESSURE CUFF

FDA 510(k)
FDA Class 2 ·Cardiovascular

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144051·R CIMA HXL PS Tibial Insert Sz A 17mm

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523172658·PS Tibia Insert Trial with Posterior Pin Relief...

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145362·R UHMWPE PS Tibial Insert Sz A 17mm

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523143283·R E-CIMA Vitamin E PS Tibial Insert Sz A 17mm

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523147502·PS Tibia Insert Trial Size A, 17mm - Right

CORE MICRO DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 22, 2011

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·November 6, 2014

2520274-2013-04474

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·July 18, 2013

EVOLUT R TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 20, 2022

STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·December 19, 2012

CODMAN Disposable Perforator, 14mm. Cranial perforator.

FDA Enforcement
Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025