13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYDRASHIFT 2/4 daratumumab
FDA 510(k)
FDA Class 2
·Immunology
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042595·Asian Non-Extraction
RANGE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INDIGO 1.0CM LASER FIBER
FDA Adverse Event
Death
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEX·June 22, 2006
OLYMPUS EVIS EXERA II PEDI VIDEO COLONSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·June 20, 2013
SHILEY DISPOSABLE CANNULA
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·July 26, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022
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