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BOVIE MEDICAL CORPORATION

US

Last updated May 24, 2026

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
079940465

Catalogue (510)

Page 1 of 11
DeviceModel / ReferenceRegistriesClassStatus
Bovie ES22-8
FDA UDI
Class IIActive
Bovie BVX-LN03
FDA UDI
Class IIActive
Bovie SE02-220
FDA UDI
Class IIActive
Bovie BV-1253BGI
FDA UDI
Class IIActive
Bovie ES53
FDA UDI
Class IIActive
Bovie A806
FDA UDI
Class IIActive
Bovie GS100-LOANER
FDA UDI
Class IIActive
Bovie ES04T
FDA UDI
Class IIActive
Bovie A1250U-V-DEMO
FDA UDI
Class IIActive
Bovie ES61HS
FDA UDI
Class IIActive
Bovie ES13R
FDA UDI
Class IIActive
Bovie ESP1TN
FDA UDI
Class IIActive
Bovie IDS-210-DEMO
FDA UDI
Class IIActive
Bovie ES51R
FDA UDI
Class IIActive
Bovie ES01T
FDA UDI
Class IIActive
Bovie IDS-400-DEMO
FDA UDI
Class IIActive
Bovie SE02
FDA UDI
Class IIActive
Bovie GP300-DEMO
FDA UDI
Class IIActive
Bovie ES22
FDA UDI
Class IIActive
Bovie CS-205T-SDV
FDA UDI
Class IIActive
Bovie IDS-200-REFURBISHED
FDA UDI
Class IIActive
Bovie ES04R
FDA UDI
Class IIActive
Bovie 0002
FDA UDI
Class IActive
Bovie ESP1HS
FDA UDI
Class IIActive
Bovie ST05
FDA UDI
Class IIActive
Bovie AA11
FDA UDI
Class IIActive
Bovie IDS-310-LOANER
FDA UDI
Class IIActive
Bovie E15624
FDA UDI
Class IIActive
Bovie® Ultimate® BVX-200H
FDA UDI
Class IIActive
Bovie ES62R
FDA UDI
Class IIActive
Bovie ES55T
FDA UDI
Class IIActive
Bovie AD-330-A2
FDA UDI
Class IIActive
Bovie AD-770R-A3W
FDA UDI
Class IIActive
Bovie® Ultimate® BVX-200P
FDA UDI
Class IIActive
Bovie ES47R
FDA UDI
Class IIActive
Bovie AR00
FDA UDI
Class IIActive
Bovie BA3390NA
FDA UDI
Class IIActive
Bovie ESP7HS
FDA UDI
Class IIActive
Bovie ESRS
FDA UDI
Class IIActive
J-Plasma® Precise™ BVX-330B
FDA UDI
Class IIActive
Bovie ES22R
FDA UDI
Class IIActive
Bovie ESP1TNH
FDA UDI
Class IIActive
Bovie NS10
FDA UDI
Class IActive
Bovie A940-DEMO
FDA UDI
Class IIActive
Bovie ES08
FDA UDI
Class IIActive
Bovie HISL
FDA UDI
Class IIActive
Bovie A824
FDA UDI
Class IIActive
J-Plasma® Precise™ BVX-150N
FDA UDI
Class IIActive
Bovie® H10012
FDA UDI
Class IIActive
Bovie AD-330R-A2W
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Feb 1, 2021Z-1153-2021—open, classified

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

Feb 1, 2021Z-1154-2021—open, classified

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

Feb 1, 2021Z-1155-2021—open, classified

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

Apr 20, 2020Z-2060-2020—terminated

Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

Apr 20, 2020Z-2061-2020—terminated

Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

Jun 18, 2018Z-0198-2019—terminated

There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.

Feb 8, 2018Z-1155-2018—terminated

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Feb 8, 2018Z-1157-2018—terminated

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Feb 8, 2018Z-1154-2018—terminated

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Feb 8, 2018Z-1156-2018—terminated

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Feb 8, 2018Z-1153-2018—terminated

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Jul 18, 2016Z-2647-2016—terminated

The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

Jul 18, 2016Z-2649-2016—terminated

The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

Jul 18, 2016Z-2648-2016—terminated

The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

Jul 18, 2016Z-2646-2016—terminated

The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.