18 results · 23ms · Sources: EU EUDAMED, 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