Data / Medical devices / United States / Beaver-Visitec International, Inc.
Beaver-Visitec International, Inc.: FDA-registered device maker in Waltham, MA, United States, 25 510(k) clearances and 2 PMA approvals
Beaver-Visitec International, Inc. is registered with the FDA (registration 1211998) in Waltham, MA, United States. It lists 54 device types. The FDA files 25 510(k) clearances and 2 PMA approvals under its listings, the newest dated April 3, 2025. 37 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1211998
- Address
- 303 Wyman St Ste 350, Waltham, MA, United States, 02451
- Owner or operator
- Beaver-Visitec International, Inc. (10033379)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 10, 2010
- Registered through
- 2026
- Brand names listed
- 45 Degree Toothed Forceps, 50 Cannula, Accu-Temp High Temperature Cautery, Accu-Temp High Temperature Cautery Handle, Accu-Temp Interchangeable Fine Tip, Accu-Temp Interchangeable Loop Tip, Accu-Temp Low Temperature Cautery, Accu-Temp Low Temperature Cautery Handle and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 3, 2025 | K240615 | Leos Laser and Endoscopy System | HQF | Substantially Equivalent | Beaver-Visitec International, Inc. | accessdata.fda.gov |
| April 17, 2017 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| August 2, 2011 | K111067 | JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE | FYA | Substantially Equivalent | Kunshan Jiehong Nonwoven Product Co., Ltd. | accessdata.fda.gov |
| June 4, 2009 | K090938 | FLOW CONTROLLER | LZU | Substantially Equivalent | Odyssey Medical, Inc. | accessdata.fda.gov |
| June 27, 2002 | K013613 | SOFT PLUG ABSORBABLE PLUG-SA | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| March 12, 2001 | K010572 | BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE | KKX | Substantially Equivalent | Becton, Dickinson and Co. | accessdata.fda.gov |
| September 9, 1997 | K972523 | PUNCTUAL OCCLUDER | LZU | Substantially Equivalent | Odyssey Medical, Inc. | accessdata.fda.gov |
| April 23, 1997 | K970631 | PUNCTUAL OCCLUDER | LZU | Substantially Equivalent | Odyssey Medical, Inc. | accessdata.fda.gov |
| February 7, 1995 | K946357 | COLLAGEN INTRACANALICULAR PLUG | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| December 27, 1993 | K933872 | VISI-SPEAR EYE SPONGE | HOZ | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| March 19, 1993 | K923922 | SURGICAL SPEARS | HOZ | Substantially Equivalent | Ultracell Medical Technologies, Inc. | accessdata.fda.gov |
| February 12, 1993 | K924542 | NASAL-SINUS PACKING | EMX | Substantially Equivalent | Ultracell Medical Technologies, Inc. | accessdata.fda.gov |
| February 1, 1993 | K920357 | ULTRACELL EAR WICK | KCN | Substantially Equivalent | Ultracell Medical Technologies, Inc. | accessdata.fda.gov |
| November 30, 1992 | K920358 | ULTRACELL NASAL PACKING | EMX | Substantially Equivalent | Ultracell Medical Technologies, Inc. | accessdata.fda.gov |
| September 30, 1992 | K923645 | VISITEC ASPIRATING SYRINGE | FMF | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| August 5, 1992 | K920354 | OPHTHALMIC SPONGES | HOZ | Substantially Equivalent | Ultracell Medical Technologies, Inc. | accessdata.fda.gov |
| May 2, 1991 | K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 | GEI | Substantially Equivalent | Mentor O & O, Inc. | accessdata.fda.gov |
| July 26, 1990 | K902750 | VISI-SWAB OPHTALMIC SPONGE | HOZ | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| May 18, 1990 | K900786 | VISI-SORB ABSORBANT STICK | HOZ | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| February 8, 1989 | K885232 | FLUID DRAINAGE WICK | HOZ | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| October 5, 1984 | K843491 | CONCEPT FIBER OPTIC CANALICULUS INTUBA | HNL | Substantially Equivalent | Concept, Inc. | accessdata.fda.gov |
| November 29, 1983 | K833648 | OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S | HAM | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
| July 12, 1983 | K831901 | LACIMAL INTUBATION SETS | HNL | Substantially Equivalent | Visitec Co. | accessdata.fda.gov |
| December 17, 1980 | K802845 | CONCEPT CANALICULUS INTUBATION SET | HNL | Substantially Equivalent | Concept, Inc. | accessdata.fda.gov |
| July 11, 1977 | K771189 | HOT TEMP CAUTERY | HQP | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 26, 2008 | P080004 | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | HQL | 45 | October 25, 2023 | accessdata.fda.gov |
| April 18, 2001 | P000046 | STAARVISC II | LZP | 31 | August 28, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 5, 2025 | 98076 | Class II | Ongoing | BVI Leos Laser and Endoscopy System. Model Number: OME6000U. | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable). | accessdata.fda.gov |
| July 26, 2024 | 95068 | Class II | Ongoing | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003 | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. | accessdata.fda.gov |
| May 10, 2024 | 94645 | Class II | Ongoing | Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227 | The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down). | accessdata.fda.gov |
| February 2, 2024 | 93951 | Class II | Ongoing | BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012 | Pack and pouch label is missing the manufacturing and expiration date. | accessdata.fda.gov |
| October 10, 2023 | 93555 | Class II | Ongoing | Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025 | One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade. | accessdata.fda.gov |
| August 25, 2023 | 93547 | Class II | Ongoing | Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807 | One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. | accessdata.fda.gov |
| March 17, 2023 | 91986 | Class II | Ongoing | CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue | Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure. | accessdata.fda.gov |
| December 20, 2022 | 91488 | Class II | Ongoing | Ultracell Wick with 80cc Collection Bag, 20/box | Device packaging may contain open seals, compromising product sterility. | accessdata.fda.gov |
| November 30, 2022 | 91235 | Class II | Ongoing | Beaver EdgeAhead Stiletto/MVR Knife.90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630 | Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection | accessdata.fda.gov |
| September 30, 2022 | 91005 | Class II | Ongoing | Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780 | Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery | accessdata.fda.gov |
| April 26, 2022 | 90237 | Class II | Ongoing | BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251 | Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250 | accessdata.fda.gov |
| November 17, 2021 | 89111 | Class II | Ongoing | Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2 | Kit packaging may have small holes compromising product sterility | accessdata.fda.gov |
| October 8, 2021 | 88826 | Class II | Ongoing | Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809 | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades | accessdata.fda.gov |
| March 12, 2019 | 82382 | Class II | Terminated | Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures | Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device | accessdata.fda.gov |
| February 19, 2019 | 82248 | Class III | Terminated | Micro Knife 5.0mm 30, Part Number 0001522 The Beaver Micro Knife 5.0mm 30 is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques.. | The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct. | accessdata.fda.gov |
| November 30, 2018 | 81757 | Class II | Terminated | BVI Visitec Soft Tip Cannula, 0.8MM.50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate | Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury. | accessdata.fda.gov |
| July 19, 2018 | 80846 | Class II | Terminated | Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from s | A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient. | accessdata.fda.gov |
| June 18, 2018 | 80565 | Class II | Terminated | Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery. | Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton. | accessdata.fda.gov |
| May 14, 2018 | 80311 | Class II | Terminated | Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery | Blades are loose in handles and may fall out due to non cured epoxy | accessdata.fda.gov |
| February 26, 2018 | 79915 | Class II | Terminated | Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549 | Products were packaged with incorrect labeling | accessdata.fda.gov |
| February 26, 2018 | 79908 | Class II | Terminated | WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures. | Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip. | accessdata.fda.gov |
| November 3, 2017 | 78789 | Class II | Terminated | 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 in ophthalmic, ENT and o | The protective shield was retracted, and the blade was exposed. | accessdata.fda.gov |
| May 1, 2015 | 71293 | Class II | Terminated | BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | accessdata.fda.gov |
| May 6, 2014 | 68281 | Class II | Terminated | Visitec Anterior Chamber Cannula,.40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These prod | Contains a sharp tip needle when the product should contain a blunt tip cannula | accessdata.fda.gov |
| February 28, 2011 | 58109 | Not yet classified | Terminated | BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture. | Loose blades in the handle of knives due to uncured epoxy. | accessdata.fda.gov |
| December 17, 2010 | 57472 | Not yet classified | Terminated | BD Visitec High Viscosity Injector 4mm.90 (20G) [Hammer] REF 585173 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured | Restricted or no fluid flow for Visitec High Viscosity Injector. | accessdata.fda.gov |
| October 4, 2010 | 57104 | Not yet classified | Terminated | Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction proc | Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury. | accessdata.fda.gov |
| April 6, 2010 | 55254 | Not yet classified | Terminated | BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surgery for sclerotomy inci | A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and that some of the BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD Visitec EdgeAhead Slit Knife 2.3mm (40 degree), REF 8009918. | accessdata.fda.gov |
| June 12, 2009 | 52291 | Not yet classified | Terminated | BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures. | Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left. | accessdata.fda.gov |
| September 15, 2008 | 49436 | Not yet classified | Terminated | BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery. | Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip. | accessdata.fda.gov |
| July 7, 2008 | 49094 | Not yet classified | Terminated | BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref: 581440 Used during cataract and other ophthalmic surgery procedures to grasp lens capsule. | Metal particulates present. | accessdata.fda.gov |
| November 20, 2007 | 45887 | Not yet classified | Terminated | BD Visitec Nucleus Hydrodissector,.40 x 22 mm, (27Gx 7/8 in), Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452 | No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow. | accessdata.fda.gov |
| August 9, 2007 | 38739 | Not yet classified | Terminated | BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD) | Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea | accessdata.fda.gov |
| March 2, 2007 | 37533 | Not yet classified | Terminated | BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618 | Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm), may contain product Ref 581617 (.50 x 16mm) | accessdata.fda.gov |
| December 26, 2006 | 37057 | Not yet classified | Terminated | BD Beaver Mini-Blade, Blade Mini Orthopedic 1.255 in, Catalog Number: 374562 | Product sterility may be compromised due to incomplete package seal | accessdata.fda.gov |
| February 28, 2006 | 34715 | Not yet classified | Terminated | BD Xstar Bevel Up Slit Knife 2.8mm, Sterile Catalog Number: 373728 | Product labeled as a 2.8 mm may contain a 3.2 mm Xstar slit knife | accessdata.fda.gov |
| September 16, 2004 | 29568 | Not yet classified | Terminated | BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240 | Blade may become detached from the handle | accessdata.fda.gov |
Compare with other makers
- All makers of Clip, Iris Retractor
- All makers of Knife, Ophthalmic
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Sponge, Ophthalmic
- All makers of Syringe, Piston
- All makers of Probe, Lachrymal
Updated December 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.