23 results
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18ms
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Sources: EU EUDAMED, US FDA
BAUER & BLACK RIGID WRIST BRACE
FDA 510(k)
FDA Class 1
·Physical Medicine
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006656·VITROS Chemistry Products Calibrator Kit 17
Phantom Tibial Preparation
FDA UDI
ADLER ORTHO SPA·08052693623501·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.1
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828017010·RETRACTOR, ALL TYPES
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551201909·Retractor, 25 x 6 mm, 21.5 cm
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756148153·ARM SLING
ACUMED
FDA UDI
Acumed LLC·10806378099502·3/4-Size Single Level ASCS INST Tray
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221217851·3M™ Unitek™ No. 5 Front-Surface Mouth Mirror, R...
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031575·Rhoton® Forceps, Straight, Fine, 178 mm
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130849·
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580170100001·SURE-SNAP 2. MOLAR UPR RGT SZ 01
flamenco™ spinal fixation system
FDA UDI
Ulrich GmbH & Co. KG·04052536021765·flamenco rod-rod-connector, parallel, ø 5.5 to ...
T-570 TINNITUS MASKER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
R3 HA Coated Acetabular Shells
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014
FEMORAL NAIL, A/R S2 10X380 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 12, 2012
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 16, 2010
28MM 0MM V40 ALUMINA HEAD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·January 22, 2015
VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 25, 2014
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026