18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
FDA 510(k)
FDA Class 1
·General Hospital
STAR
FDA UDI
Stryker GmbH·00886385017280·Tibial Cut Block Assembly, RIGHT
Symmetry Malis®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139738·Titanium Malis Style Straight Bipolar Forceps, ...
Plate Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043780·
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935105268·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631151·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631168·
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
5C-ES CELL CONTROL, MODELS 7547191, 7547192
FDA 510(k)
FDA Class 2
·Hematology
UNICEL® DXC 600 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·April 26, 2013
CATH PKGD: BERMAN 4 FR 5 0CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQO·April 7, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
UNSPECIFIED BD CATHETER NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·October 24, 2023
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2015
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·September 22, 2016
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014