Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1211998

FEI Number

1211998

Entity Name

Beaver-Visitec International, Inc.

City/State/Country

Waltham, MA, US

Establishment Address

303 Wyman St Ste 350, Waltham, MA 02451, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Beaver-Visitec International, Inc. (Owner Number: 10033379)

Owner / Operator Contact Address

500 Totten Pond Rd, 10 CityPoint, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BVI Isolation Gown US AMMI Level 2 Visitec Lacrimal Intubation Set DCR Set angled O Donoghue Punctal Dilator and Probe DCR Set straight O Donoghue Lacrimal Intubation Set with retrieval Device Vannas Scissors Dressing Scissors Metzenbaum Scissors Castroviejo Corneoscleral Scissors Enucleation Scissors Westcott Scissors, Straight, Pointed Castroviejo Scissors Iris Scissors Curved Iris Scissors Nurses Blunt Scissors Mayo Scissors Stevens Tenotomy Westcott Scissors, Curved, Pointed Westcott Scissors Sharp Blunt Scissors Iris Dissecting Scissors Vannas Scissors, Curved IOL Cutter (Osher) Dressing Scissors, Straight, Rounded Ong Capsule Scissors Westcott Scissors, Straight, Rounded Castroviejo Scissors, Straight, Rounded Westcott Scissors, Curved, Dolphin Nose Vannas Scissors, Straight Iris Scissors, Curved, Pointed Stevens Tenotomy, Straight, Rounded Clip - Sprung Scissors (Pair) Clip - Micro Sprung Scissors (Pair) Extend 180 Synthetic Implants (0.4mm x 2mm) Extend 180 Synthetic Implants 1 Pair (0.3mm x 2mm) Extend 180 Synthetic Implants 1 Pair (0.5mm x 2mm) Extend 180 Synthetic Implants (0.5mm x 2mm) Extend 180 Synthetic Implants Variety Pack Extend 180 Synthetic Implants 10 Pairs (0.3mm x 2mm) Ultracell® Ear Wick 9 x15 mm Ultracell® Ear Wick Fenestrated Long 9 x 24 mm Ultracell® Pediatric Ear Wick Long 7 x 20 mm Ultracell® Ear Wick Long 9 x 24 mm Ultracell® Pediatric Ear Wick Fenestrated 7 x 20 mm Ultracell® Pediatric Eye Wick 7 x 12 mm Accu-Temp High Temperature Cautery Handle Accu-Temp Interchangeable Fine Tip Accu-Temp Low Temperature Cautery Handle Accu-Temp Interchangeable Loop Tip Ultracell PVA Eye Spears Ultracell Cellulose Eye Spears UltraClean LASIK PVA Eye Spears UltraClean LASIK Expanded Eye Spears Castroviejo Caliper Visitec Reuable Insertion Instrument Lacrimal Probe Bowmans Probes Punctum Dilator Punctum Dilator/Lacrimal Probe Bowmans Probes, Size 00-0 Punctum Seeker Punctum Dilator, Medium Canaliculus Intubation Set (CIS) Golf Club Spud Canaliculus Intubation Set (CIS) 15.5 cm long Guibor Canaliculus Intubation Set (CIS) LASIK Drain Banaji BVI Ophthalmic Cannula Bishop Harmon Cannula Small Incision Irrigating Vectis Transcleral Drainage Cannula LASIK Flap Irrigator Posterior Scraper Cortex Extractor ViscoExpression Cannula Visitec Nucleus Hydrodissector Irrigating Cannulas Infusion Cannulas LASIK Flap Spatula/Irrigator Anterior Chamber Cannula Anterior Chamber Cannula [Rycroft] Silicone Oil Removal Cannula Micro Irrigating Vectis Tapered Hydrodelineator Membrane Micropick Visitec Irrigation Handle 50 Cannula Viscoflow® Cannula High Viscosity Injector I and A Cannula Vitreoretinal Brush LASIK Cannula Lacrimal Cannula Coaxial I and A Cannula Leatherbarrow Pellet Insertion Cannula 5 SP Vitreoretinal Cannula Capsule Polisher HydroExpression Cannula Sub-Tenons Anesthesia Cannula Micro J Shape Hydrodissector Subretinal Injector FLACS Cannula J Shape Cannula Olive Tip Cannula LASEK Cannula Nucleus Hydrodissector LASIK Irrigating Cannula Subretinal Fluid Cannula Micro J Shape Cannula Soft Tip Cannula Irrigating Vectis Cortical Cleaving Hydrodissector Olive Tip Polisher Flexible Tip Cannula Bimanual Irrigation Cannula Barron Scalpel Handle Flat Beaver Blade Wrench Dynagrip Handle and Wrench 4mm Artho-Lok Handle and Wrench 4mm Beaver Handle (Round Knurled Stainless) Beaver BeaverTail Flat Handle Lens Handle Scalpel Blade Handle With Gradations Beaver Handle Beaver Replacement Chuck Collet Visitec® Irrigation Handle Visitec® Single Fluid Administration Set Visitec® Double Male Luer Visitec® High Flow Filter Visitec® Absorbent Stick Visitec Surgical Glide [Fichman] 30 x 5mm Visitec Small Pupil IOL [Pearce] 33 x 7mm Visitec IOL Glide [Hessburg] 18 x 7mm Visitec Phaco Glide [Bobbit] 20 x 2.75mm Visitec IOL Glide [Sheets] 35 x 5mm Beyeonics One Guibor Eye Bubble Bandage Eye Patch Universal Eye Shield Left/Right Eye Shield Beaver Artho-Lok Mini-Banana Blade Beaver Artho-Lok Mini-Meniscus Blade Beaver Artho-Lok Round Tip Blade Beaver Arthro-Lok Pointed Tip Curve Blade Beaver Artho-Lok Mini-Meniscus Blade (Flat) Beaver Artho-Lok Blade Hoe Blade Beaver Arthro-Lok Pointed Retrograde Blade Beaver Artho-Lok Round Tip (Flat) Beaver Artho-Lok Retrograde Blade Beaver Artho-Lok Banana Blade Chalazion Curette Double 02mm/03mm Chalazion Curette Chalazion Curette, Double, 01mm/02mm LASIK Flap Separator/Elevator Epithelium Well X-Ray Pointer Eye Guard LASIK Cap / Flap Elevator, Kritzinger-Updegraff LASIK Flap Separator LASIK Flap Separator/Elevator (Seibel) Reinstein Lenticule Separato Single use instrument tray Sunalp Epithelium Well Trephining Reinstein Lenticule Separator (Hyperopic) ReLEx Pocketing Hook/Separator Birks Tying Forceps LASIK Flap Roller, [Lindstrom], 14mm Micro Retractor, Pearce, 30 degrees Chalazion Curette 2mm LASIK Flap Separator & Elevator (Binder) LASIK Flap Separator/Elevator, Curved Epithelium Well, 8.5mm LASEK Microhoe, (Yee), Formed tip, 12mm from end Corneal Epithelium Spatula, Flat Punctum Dilator/Seeker Fine Toothed Forceps Short (Bonn) Straight Tying Forceps Short Barraquer Speculum, Solid 18mm Blade (PC) LASIK Flap Elevator, Curved, 8mm Jewellers Forceps Curved/Plain Punctum Plug Forceps LASIK Flap-Lifting Forceps Iris Scissors Straight, Pointed LASIK Flap Separator/Elevator Straight Toothed Forceps (Bonn) IOL Removal Forceps Malosa® Neonatal Speculum LASIK Flap Separator, Flattened Tip Double-Ended Evisceration Spoon Evisceration Spoon Paton Spatula/Spoon Visitec Fiberoptic Canaliculus Intubation Set CustomEyes® Plus Punctal Occluder Plus Pre-loaded Punctal Occluder iPure Preloaded IOL System (Models B3PC) IPure Preloaded IOL System (Models B1PC) iPure Preloaded IOL System (Models B3PY) IPure Preloaded IOL System (Models B1PY) Nasal Pack with Tube Nasal Pack Nasal Slimpack Ultaplus Nonstick Nasal Slimpak with Sleeve Ultraplus 5000 Nonstick Nasal Pack Single Folded Nasal Pack Ultraplus Nonstick Nasal Pack with Sleeve Nasal Pack with String Trabeculectomy Punch Titanium Beaver Myringotomy Blade Beaver Myringotomy Knife IOL Removal Forceps 45 Degree Toothed Forceps Sclerectomy Forceps Thornton Fixation Ring Fine Stem Toothed Forceps Max Fine Micro-Corneal Forceps Fine Toothed Forceps Iris Pointed Forceps Iris Fine Toothed Forceps Fixation Ring Jewellers Forceps Contact Lens Forceps Moorfields Forceps Corneal Ring Forceps - Keraring Bishops Forceps Lens Folding Forceps Straight Rampley Scleral Plug Forceps Lenticule Extraction Forceps Kocaba DMEK Forceps Single Use Instrument, Bonn Forceps MICS Capsulorhexis - Straight/Sharp Crocodile Forceps Halstead Mosquito Jewellers Forceps Angled Micro Cross-Action Bulldog Clamp Angled Tying Forceps (McPherson) Epilation Forceps Jewellers Forceps, Fine Angled Curved Tying Forceps Capsulorhexis Forceps Toothed Forceps Birks Tying Forceps IOL Implantation Forceps Straight Tying Forceps, Short Straight Tying Forceps Catford Forceps Jewellers Forceps, Fine Straight Colibri Toothed Forceps St Martins Forceps Backhaus Towel Clip Meibomian Gland Forceps Kelly Forceps Punctum Plug Forceps Adson Forceps Toothed LASIK Flap-Lifting Forceps Colibri Notched Forceps Toothed Forceps (Bonn) Spencer Wells Artery Forceps Waqar Suture Removal Forceps Waughs Dissecting Forceps Fine Notched Forceps Short (Hoskins) MICS Capsulorhexis MICS Capsulorhexis - Straight/Blunt Colibri Toothed Forceps, Short Adson Forceps Non-Toothed Lens Loading Forceps Jayles Forceps Iris Pointed Forceps, 105mm Notched Forceps (Hoskins) Clip - Long Handled Forceps (Pair) MICRO FLOW, BVI, Beaver-Visitec International Micro Flow Pre-loaded Punctal Occluder Micro Flow Punctal Occluder I-Ring® Pupil Expander Beaver® Swivel Fixation Ring Visitec Visiswab Cotton Swab Visitec Corneal Light Shield Visitec LASIK PVA Eye Drain (Cheyet) Visitec Cellulose Eye Spear Visitec Sponge Visitec LASIK PVA Expanded Eye Spear Visitec LASIK Eye Drain (Banaji) Visitec LASIK PVA Eye Spears Visitec Visiwipe Instrument Wipes Desmarres Lid Retractor, Medium Fisons Retractor Langenbach Retractor Cats Paw Retractor Aufricht Nasal Retractor Desmarres Lid Retractor Desmarres Lid Retractor, Small Pointed IVT Marker Intravitreal Injection Guide Braunstein IVT Marker, 3.5/4mm Braunstein IVT Marker Double Ended IVT Guide Pad Pointed IVT Marker 3.5/4mm, Blue Weck-Cel Sponge Points Weck-Cel Cellulose Eye Spear Merocel Eye Wick Keracel LASIK Corneal Shield Merocel Corneal Light Shield BVI, Beaver-Visitec International, Weck-cel, Merocel, Keracel Keracel LASIK Spear Kit Keracel Chayet Drainage Ring Keracel Cleanfield LASIK Kit Keracel LASIK PVA Eye Spears Merocel Sponge Points Merocel Instrument Wipes Merocel Hardten Cover Merocel Fluid Collection Bag with Wick Merocel Instrument Wipe Kit Merocel Eye Kit Keracel Yavitz Flap Cover Ophthalmic Surgery Kit Merocel PVA Eye Spears Merocel Cataract Kit Visitec Eye Fluid Wick Visitec Microsurgical Accessory Kit Weck-Cel Sponge Points and Strips Merocel Crystal Anesthesia Ring Karacel Yavitz Drainage Ring & Flap Cover Beaver Tympanoplasty Blade Beaver Sickle Edge Blade Accu-Temp High Temperature Cautery Accu-Temp Low Temperature Cautery Deluxe Patient Pack Standard Patient Pack Malosa Core LASIK Pack 2 Malosa IVT Pack Malosa Phaco Kit Readypak Malosa Strabismus Pack Malosa Corneal Pack Malosa Core SMILE Pack Malosa Core LASIK Pack Malosa Chalazion Pack Malosa Paediatric Retinal Exam Pack Malosa IVT Dual Marker Pack Malosa Core Surface Treatment Pack Malosa Sub-Tenons Pack Malosa Core Phaco Pack Malosa Oculoplastic Suture Pack Malosa Core SMILE Pack 1 Sharp Cystotome, straight Sharp Point Cystotome Blunt Tip Irrigating Cystotome Irrigating Cystotome GLAUCOMA REVISION PICK Visitec, Visisorb Beaver, BVI Beaver Visitec International Beaver® Myringotomy Blade Upcutting Tip, 45 Degree Beaver® Spear Tip Myringotomy Knife 45 Degree Beaver® Myringotomy Blade Downcutting Tip 45 Degree Beaver® Tympanoplasty Blade, 2.5mm W, 60 Degree Bevel Down Beaver® Tympanoplasty Blade, 2.5mm W Straight Beaver® Myringotomy Knife, Lance Tip 45 Degree Beaver® Myringotomy Blade, Offset 45 Degree BVI Maxi-Lite Diagnostic Penlight BVI Nurse-Mate Six Pack Diagnostic Penlight BVI Blu-Spot® Diagnostic Penlight BVI Doctor's Six Pack Diagnostic Penlight Ultracell 8 cm Anatomical Nasal Pack Ultracell 4.5 cm Classic Nasal Pack with String Ultracell 10 cm Classic Nasal Pack with String Ultracell 8 cm Classic Nasal Pack with String Collagen Temporary Implants 0.3mm x 2mm Collagen Temporary Implants 0.4mm x 2mm Collagen Implants Variety Pack Collagen Temporary Implants 0.2mm x 2mm Beaver Ring Cutter Hub Beaver Ring Cutter Beaver Ring Cutter Saw Blade Beaver Ring Cutter Washer Ayliffe Chopper/Chopper Claw Chopper Kuglen Hook Greens Chopper Sadiq Chopper Ursell Chopper/Manipulator Corneal Ring Pocket Spreader Epithelium Hoe Denis Nucleus Chopper Vertical Y Manipulator Drysdale Manipulator Diablo Manipulator Mushroom Manipulator Epithelium Hoe Curved Button Manipulator LASIK Flap Elevator Curved Reverse Sinskey Butcher Rotator ICL Manipulator Button Tip Manipulator, (45 Degree) Horizontal Chopper/Kuglen Hook Govan Manipulator Flat Round Tip Manipulator LASIK Flap Elevator Pointed Greens Chopper, Right Handed Koch Chopper, 1.4mm, Thin Shaft Hagege Manipulator Horizontal Y Manipulator Sinskey Hook Straight Corneal Ring Pocketing Hook Phaco Chopper/Mushroom Manipulator Sinskey Hook Ball Tip Muscle Hook Seibel Nucleus Chopper Nagahara Chopper Rosen Chopper Neuhann Nucleus Divider McPherson Manipulator Diablo Chopper/Flat Button Manipulator Curved Muscle Hook Phaco Chopper Chevasse Muscle Hook Koch Chopper, 1.4mm Reverse Dialling Hook Koch Chopper 1.4mm/Button Manipulator Lester Hook Lebuisson Manipulator Kuglen Hook Angled Sinskey Hook, 0.2mm Kuglen Hook, Straight Nucleus Chopper, [P.Koch], (45 Degree) Micro Iris Hooks, [Engels], 8mm long x 8mm diameter IOL Manipulator, [Lester], .25mm IOL Manipulator, [Sinskey], Blunt tip Nucleus Rotator Peribulbar Retrobulbar Parasol® Pre-Loaded Punctal Occluder Medium 0.6mm 0.85mm Parasol® Quickload Punctal Occluder Large 0.9mm+ Parasol® Pre-Loaded Punctal Occluder Small 0.35mm 0.65mm Parasol® Punctal Occluder Bulk NS Large 0.9mm+ Parasol® Pre-Loaded Punctal Occluder Large 0.9mm+ Parasol® Quickload Punctal Occluder Combo Pack Small Medium Parasol® Quickload Punctal Occluder Small 0.35mm 0.65mm Parasol® Punctal Occluder Bulk NS Small 0.35-0.65mm Parasol® Quickload Punctal Occluder Medium 0.6mm 0.85mm Parasol® Pre-Loaded Punctal Occluder X-Small 0.25mm 0.35mm Parasol® Punctal Occluder Bulk NS Medium 0.6-0.85mm Parasol® Punctal Occluder Bulk NS Combo Small/Medium Infant Speculum Wire Eye Speculum Clarke Speculum Kratz-Barraquer Cook Neonatal Speculum Barrett Speculum Mechanical Speculum Paediatric Speculum Pierce Adjustable Speculum Corcelle Speculum Solid Blade Sauer Neonatal Speculum Kratz-Barraquer Speculum, Curved Neonatal Speculum Paediatric Mechanical Speculum Single use instrument tray Dr. Sunalp Barraquer Speculum Alphonso Paediatric Speculum IOL Manipulator, Jaffe - Maltzman, Blunt tip 45 degree Kratz-Barraquer Speculum Kratz-Barraquer Speculum, Temporal Barraquer Speculum, Solid Blade (PC) Barraquer Speculum, Flat Blade Mechanical Speculum, Open Blade (PC)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-01
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2020-03-10
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2017-11-08
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2020-07-02
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2014-06-17
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2019-04-01
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-08-15
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2010-08-11
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-20
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2014-12-21
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-04-04
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-10
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2010-08-11
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2010-08-11
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2025-05-09
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2018-11-29
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2010-08-11
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2022-05-17
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2010-08-11
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2021-11-24
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2012-08-07
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-20
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2014-12-21
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-08-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2020-05-12
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-24
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2012-12-14
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2010-08-17
JYP	Knife, Myringotomy	Ear, Nose, Throat	Class 1	874.4420	2021-11-24
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2010-08-11
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2018-11-29
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-04-04
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-20
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2016-07-11
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2010-08-11
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2021-11-24
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2025-01-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2012-12-14
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2021-05-18
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2010-08-11
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2014-03-31
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2010-08-11
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2010-08-17
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2020-07-02
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2010-08-11
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-07-23
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Beaver-Visitec International, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012539515	Rio Bravo International Inc	El Paso, TX, US
3012733432	Malosa Medical Instruments (Changshu) Limited	Changshu Jiangsu, CN
2247224	Beaver-Visitec International, Inc	Little Silver, NJ, US
3013466775	Grupo American Industries, S.A. de C.V	Ciudad Juarez Chihuahua, MX
3013421458	Beaver-Visitec International, Inc.	Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K834060	F. & F. Koenigkramer	RELIANCE OPHTHALMIC SLIT LAMP R-083	1984-02-04
K823222	American Medical Optics	INTRAOCULAR LENS GUIDE	1982-12-28
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0835-2025	Alcon Research LLC	1	Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
Z-0275-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1211998. Last updated year: 2026. Please use registration number 1211998 when referencing this establishment in official correspondence.