36 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Philips Incisive CT
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517293541·CoRoent XL-FW Drill, Self-Centering
BALANCE HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304268654·
Suprasorb P Sensitive Ag
FDA UDI
L&R USA INC.·04063591428185·
GUIDED GROWTH PLATE SYSTEM
FDA UDI
ORTHOFIX SRL·18054242518051·GUIDED GROWTH PLATE BENDER
Batrik Brush/Green/BD 15mm/BL 50mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521008991·Brush/Green/BD 15mm/BL 50mm/OL 75cm - Rigid - R...
Prelude EASE™ Hydrophilic Sheath
FDA UDI
Merit Medical Systems, Inc.·00884450284513·
Batrik Brush/Green/BD 15mm/BL 50mm-SN
FDA UDI
Batrik Medical Manufacturing Inc·00690521009004·Brush/Green/BD 15mm/BL 50mm/OL 75cm - Rigid - S...
Patella Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215064020·
Spetzler-Malis
FDA UDI
STRYKER CORPORATION·07613327300376·Disposable Standard Bipolar Forceps, Non-Stick,
Spetzler-Malis
FDA UDI
STRYKER CORPORATION·07613327300321·Disposable Dual Irrigating Bipolar Forceps, Non...
Malis
FDA UDI
STRYKER CORPORATION·07613327693362·Disposable Standard Bipolar Forceps, Non-Stick,
iNSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127027147·Shortened Dual Tapered, Femoral Stem, Size 15, ...
Meduloc Intramedullary Fracture Fixation (IFF) System
FDA UDI
MEDULOC, LLC·00810184540205·Bone Anchor Screw (1.5)
VITALSENS, AINGEAL, V-POD
FDA 510(k)
FDA Class 2
·Cardiovascular
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
FDA 510(k)
FDA Class 2
·Immunology
Quick-Core
FDA UDI
COOK INCORPORATED·00827002187054·Quick-Core, Biopsy Needle
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 11, 2020
STAIR PRO - MODEL 6252
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPP·June 20, 2013
MAXFIRE WITH ZIPLOOP
FDA Adverse Event
Malfunction
·BIOMET SPORTS MEDICINE·Product code JDR·July 27, 2011