36 results · 31ms · Sources: EU EUDAMED, 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