15 results · 22ms · Sources: EU EUDAMED, US FDA

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ProCell Surgical Sponge-Blood Recovery Unit

FDA 510(k)
FDA Class 2 ·Anesthesiology

Contrast Line

FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207459·Contrast Line 48"(122cm) Male/Female Polyuretha...

SYNTHES AIR PEN DRIVE (APD) SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

SECURIS SPINAL FIXATION

FDA 510(k)
FDA Class 2 ·Orthopedic

EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023

PRECISION

FDA Adverse Event
Malfunction ·ADVANCED BIONICS CORP.·Product code LGW·October 7, 2008

MW5030651

FDA Adverse Event
Injury ·June 21, 2013

CMAX SURGICAL TABLE

FDA Adverse Event
STERIS CORPORATION - MONTGOMERY·Product code FQO·August 5, 2011

SENSITHERM PROBE

FDA Adverse Event
Injury ·FIAB S.P.A.·Product code FLL·July 10, 2023

SMALL ELECTRIC DRIVE

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018