16 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564031631·MINOR BASIN SET

ArgenIS

FDA UDI
ARGEN CORPORATION, THE·D818120963·BIO 5.7 Ti Blank

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·August 13, 2008

OCTRODE PERCUTANEOUS LEAD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

SOMATOM Perspective (Model 10495568)

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 8, 2018

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

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024