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