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