20 results · 21ms · Sources: EU EUDAMED, US FDA

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SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

JOBST UltraSheer

FDA UDI
BSN MEDICAL, INC.·00035664215125·ULTRA SHEER 20-30 MM HG WAIST HIGH CLOSED TOE S...

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032294·CHEST/BREAST & ENT PACK

Health Support

FDA UDI
Carolon Company·00078301121526·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311215120·

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321215120·

Cervical Interbody 15mm x 13mm x 12mm Packaging

FDA UDI
XENCO MEDICAL LLC·B064XM11215121·Cervical Interbody 15mm x 13mm x 12mm

CancelleX™ 15mm x 13mm x 12mm Cervical Interbody

FDA UDI
XENCO MEDICAL LLC·B064XM3D31215121·

MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4).

FDA 510(k)
FDA Class 2 ·Cardiovascular

COBAS INTEGRA ONLINE DAT II METHADONE II

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MiniSPC Button

FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071152192·12F x 1.5cm MiniSPC Low Profile Suprapubic Cath...

ACCELERATOR A3600

FDA Adverse Event
Malfunction ·INPECO SA·Product code JQP·December 20, 2024

OPT SLEEVE 12X100 STABILITY

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019

IDENTITY ADX XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

TENSION FREE VAGINAL TAPE

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

CONTOUR TEST STRIPS

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·May 6, 2011

EGIA 45 ARTICULATING MED/THICK SULU

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015

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

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018