16 results · 28ms · Sources: EU EUDAMED, US FDA

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S. AUREUS/CNS PNA FISH, MODEL KT005

FDA 510(k)
FDA Class 1 ·Microbiology

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122802·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 150mm

Symmetry Farrell

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482037911·Applicator, Farrell Cotton, Triangular End, 6 1...

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962109014·FARRELL COTTON APPLICATOR, 6 1/4", TRIANGULAR END

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

FDA 510(k)
FDA Class 1 ·Microbiology

NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)

FDA 510(k)
FDA Class 1 ·General Hospital

EDWARDS SAPIEN TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·May 3, 2013

PENTA

FDA Adverse Event
Injury ·ST. JUDE MED - NEUROMODULATION·Product code GZB·September 3, 2014

INFINITI VISION SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 27, 2011

FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020

FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 17, 2018

FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 22, 2020

HAHN TAPERED IMPLANT 3.0 X 11.5MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 26, 2022

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024