11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Scooter, Model: R-100
FDA 510(k)
FDA Class 2
·Physical Medicine
OsteoMed
FDA UDI
OSTEOMED LLC·00842528128916·2.4mm x 11mm Cannulated Lag Screw
Symetri Clear
FDA UDI
ORMCO CORPORATION·00889989084665·L3L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI...
8.2MHZ MICROVASCULAR PROBE
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787020984·
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 11, 2022
J-SCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAMMOTOME ELITE BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code MUZ·July 11, 2011
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 21, 2013
1.5X5MM HT SD X-DRIVE SCREW
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code HWC·September 12, 2008
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