18 results · 25ms · Sources: EU EUDAMED, US FDA

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UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT

FDA 510(k)
FDA Class 2 ·Hematology

Spherodon - M

FDA UDI
SILMET LTD·07290012207402·Dental Amalgam Capsules

JOBST UltraSheer

FDA UDI
BSN MEDICAL, INC.·00035664214920·USH 30-40 KH CT L SUNT 1 EN FR ES

AF541

FDA UDI
Respironics, Inc.·00606959024489·AF541 Mask with Entrainment Elbow, Leak 1, with...

8 CHANNEL CARDIAC PHASED ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

ALT HA S CLR EXT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code MEH·November 14, 2023

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 19, 2025

PROLIFT PELVIC FLOOR REPAIR

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTP·May 21, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

DEXTRUS 4136

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·June 7, 2011

NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·May 31, 2024

NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·August 12, 2024

BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·October 3, 2024

NV GXL LINER LIPPED 36MM ID GROUP 2

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·November 1, 2022

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015