14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C2 Xplore
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
V-Strap Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232543·
SPEEDICATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRASOUND SCANNER FLEX FOCUS
FDA 510(k)
FDA Class 2
·Radiology
FREESTYLE LIBRE 3 PLUS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QBJ·May 19, 2026
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 4, 2014
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·August 16, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 20, 2024
COPAN WASP/COLIBRI
FDA Adverse Event
Other
·COPAN WASP·Product code QQV·July 25, 2024
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 18, 2024
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
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025