ClearanceBrief
Panels › General, Plastic Surgery › Product code EMF · Class 1

Knife, Surgical

Regulation 878.4800

0510(k)s in 12 months (21 all time)
0recalls in 12 months (9 all time)
1recalls that name a 510(k)
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Top companies in EMF

DateFirm and productCodeLinked 510(k)
Jun 12, 2025MicroAire Surgical Instruments, LLC
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartR
Open, Classified
EMFK223406
May 18, 2020Carefusion 2200 Inc
Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Terminated
EMFNone listed
May 14, 2018Beaver Visitec
Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
Terminated
EMFNone listed
Feb 1, 2018Beaver-Visitec International Inc.
bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and
Terminated
EMFNone listed
Feb 1, 2018Beaver-Visitec International Inc.
bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Terminated
EMFNone listed
Feb 1, 2018Beaver-Visitec International Inc.
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
Terminated
EMFNone listed
Feb 1, 2018Beaver-Visitec International Inc.
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in op
Terminated
EMFNone listed
Feb 1, 2018Beaver-Visitec International Inc.
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions
Terminated
EMFNone listed
Jul 1, 2013Surgical Instrument Service And Savings, Inc.
-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF
Terminated
EMFNone listed

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