82 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STRYKER PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014
HANKS' BALANCED SALTS NO. 210-3010
FDA 510(k)
FDA Class 1
·Hematology
UNI-ELBOW
FDA UDI
Stryker GmbH·00886385026060·Radio Capitellum, Trial, Handle Uni-Elbow
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193108162·HA PEEK EVOS Straight, ,10mmx9mmx 22mm , FLAT ...
STEFAN BONE HOLDING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896050709·STEFAN BONE HOLDING FORCEPS WITH SPEED LOCK CUR...
E-A-RTONE™
FDA UDI
3M COMPANY·00080529191205·3M(TM) E-A-RTONE(TM) Insert Earphone 3A 10 ohm ...
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828195232·
Altus Spine Cervical Interbody Fusion System
FDA UDI
Altus Spine, LLC·00843210131160·Rasp, No Tab
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828149099·GEN4 INTERACTIVE
HDL CHOLESTEROL (HDLX) ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPIRIT ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00845694043328·Chin Plate 6mm with Screws, Sterile
QuicKlear®
FDA UDI
Forestadent Bernhard Förster GmbH·EFORC73701030101·QuicKlear Bracket Roncone .018" PhysioDynamic S...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78801030101·Mini Sprint Bracket Roth .018" max. 1 right
TruKlear®
FDA UDI
Forestadent Bernhard Förster GmbH·EFORC71501030101·TruKlear Bracket McLaugh/Benn/Trev. .018" max. ...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78401030101·Micro Sprint Bracket Roth .018" max. 1 right
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR73101030101·BioQuick Bracket Roth .018" max. 1 right
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR73601030101·BioQuick Bracket Roncone .018" PhysioDynamic Sy...
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR73001030101·BioQuick Bracket Roth .018" max. 1 left