17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PowerX Lipo System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169599116·TRIAL 2190555 O25 IB 27MM 0 DEG 16X55
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042366·4 Bicuspid Extraction w/Seating Springs
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055001·MTM® NO TRACE (TM) 018 UL/4-4
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055011·IN-OVATION® L 018 UPPER 6-6
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055101·IN-OVATION® L 018 UL/7-7
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
FDA 510(k)
FDA Class 2
·Orthopedic
CADD SOLIS VIP PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·April 4, 2023
AFFINITY 3
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·October 2, 2008
CVC SET: 4 FR X 19-1/2
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code LJS·June 21, 2013
DALE PEDIATRIC TRACHEOSTOMY TUBE HOLDER
FDA Adverse Event
Malfunction
·DALE MEDICAL PRODUCTS·Product code CBH·October 16, 2007
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·May 6, 2022
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
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