Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

ZYWIE, INC.

GA/USA

3012164459

2026

medical device data system

Manufacturer

ZYTOVISION GMBH

GERMANY

3005704042

2026

general purpose reagent - 100x Wash Buffer; 10x MgCl2; 10x PBS; 20x Wash Buffer TBS; 25x Wash Buffer A; 5x FlexISH Wash Buffer; AEC Solution; Anti-Biotin/DIG-Mix; Anti-DIG/DNP-Mix; Anti-Mouse-HRP-Polymer; AP-Red Solution A; AP-Red Solution B; Blocking Solution; Blue Spot Solution; Cytology Pepsin Solution; Cytology Stringency Wash Buffer SSC; Cytology Wash Buffer SSC; DAB Solution A; DAB Solution B; DAB Solution Set; DAPI/DuraTect-Solution; DAPI/DuraTect-Solution (ultra); Detection Solution; FlexISH-Tissue Implementation Kit; Formaldehyde Dilution Buffer Set; Heat Pretreatment Solution Citric; Heat Pretreatment Solution EDTA; HRP-Green Solution A; HRP-Green Solution B; HRP/AP-Polymer-Mix; Hybridization Solution; Mayer's Hematoxylin Solution; Mounting Solution (alcoholic); Mounting Solution (aqueous); Mouse-anti-DIG; NBT/BCIP Solution; Nuclear Blue Solution; Nuclear Green Solution; PBS/Tween; Pepsin Solution; Permanent Red Solution A; Permanent Red Solution B; VisionArray Detection Kit; VisionArray MultiScan Software; VisionArray Myco Chip 2.0; Wash Buffer SSC; ZyBlack Quenching Solution; ZytoDot 2C CISH Implementation Kit; ZytoDot AP-Red Solution Set; ZytoDot CISH Implementation Kit; ZytoDot HRP-Green Solution Set; ZytoFast PLUS CISH Implementation Kit HRP-DAB; ZytoLight FISH-Cytology Implementation Kit; ZytoLight FISH-Tissue Implementation Kit

Manufacturer

ZYTO Technologies, Inc.

UT/USA

3008493238

2026

device, galvanic skin response measurement - ZYTO Hand Cradle

Manufacturer

medical device data system - ZYTO Software

Manufacturer; Complaint File Establishment

ZYRIS, INC.

CA/USA

2032574

2026

accessories, retractor, dental - ISODRY; ISOLITE; Isolite Anterior Isolation System; Isovac; Operating Room Adapter (ORA); Zyris Lip Retractor

Manufacturer

unit, suction operatory - Isodry; Isolite 3; Isolite Pro; Isovac; Isovac 2

Manufacturer

mouthpiece, saliva ejector - Isolite Mouthpiece

Specification Developer

Zyno Medical LLC.

MA/USA

3006575795

2026

pump, infusion - Multiple models, pump and IV sets

Manufacturer; Specification Developer

set, administration, intravascular - Blood set

Manufacturer; Specification Developer

set, administration, intravascular - Zyno Administration Sets

Manufacturer; Specification Developer

pump, infusion - Z-800 Series Volumetric Infusion System

Manufacturer; Specification Developer

set, administration, intravascular - Zyno Medical Administration Sets

Manufacturer; Specification Developer

ZYNO ELECTRIC & MACHINERY LTD, SHANGHAI

CHINA

3011688490

2026

pump, infusion - Z-800 Infusion System, Z-800,Z-800W,Z-800F,Z-800WF

Contract Manufacturer

ZYNEX MEDICAL, INC.

CO/USA

1723686

2026

stimulator, nerve, transcutaneous, for pain relief - TENSWave

Manufacturer

ZYNEX MEDICAL, INC.

CO/USA

3017936974

2026

stimulator, electrical, non-implantable, for incontinence - InWave

Manufacturer

stimulator, nerve, transcutaneous, for pain relief - NexWave

Manufacturer

stimulator, muscle, powered - NexWave

Manufacturer

interferential current therapy - NexWave

Manufacturer

device, biofeedback - NeuroMove NM900

Manufacturer

Show all 10 Listings for ZYNEX MEDICAL, INC. CO/USA

ZYLOX-TONBRIDGE MEDICAL TECHNOLOGY CO., LTD.

CHINA

3038165043

2026

catheter, peripheral, atherectomy

Manufacturer

system, imaging, optical coherence tomography (oct)

Manufacturer

catheter, peripheral, atherectomy

Manufacturer

system, imaging, optical coherence tomography (oct)

Manufacturer

catheter, peripheral, atherectomy

Manufacturer

Show all 10 Listings for ZYLOX-TONBRIDGE MEDICAL TECHNOLOGY CO., LTD. CHINA

ZYLOWARE LLC

NY/USA

2428194

2026

frame, spectacle - Daisy Fuentes; Gloria Vanderbilt Eyewear; Invincilites by Zyloware; Leon Max; Max Studio.com; Project Runway Eyewear; Randy Jackson Eyewear; shaq; Shaq Eyegear; Shaquille O' Neal Eyewear; Sophia Loren Eyewear; Stetson; Via Spiga

Repackager/Relabeler

ZYLLION, INC.

CA/USA

3009225484

2026

massager, therapeutic, electric

Repackager/Relabeler

ZygoFix

ISRAEL

3031232974

2026

system, facet screw spinal device - zLOCK Lumbar Facet Fixation System

Manufacturer

system, facet screw spinal device - zLOCK Lumbar Facet Fixation System

Manufacturer

ZYBIO INC.

CHINA

3017098905

2026

clinical sample concentrator - Nucleic Acid Isolation System; Nucleic Acid Extraction Kit (Magnetic Bead Method)

Manufacturer

analyzer, chemistry (photometric, discrete), for clinical use - EXC200 Chemistry Analyzer

Manufacturer

ZURIMED TECHNOLOGIES INC.

DE/USA

3034991516

2026

ZURIMED TECHNOLOGIES AG

SWITZERLAND

3034932459

2026

mesh, surgical, non-absorbable, orthopaedics, reinforcement of tendon - FiberLocker Implant; FiberLocker Instrument; FiberLocker System; SpeedPatch PET

Manufacturer; Complaint File Establishment

instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - FiberLocker PowerUnit; FiberLocker PowerUnit Charging Station; FiberLocker PowerUnit Handpiece; FiberLocker PowerUnit Motor Pack; FiberLocker PowerUnit Transfer Shield; PowerUnit Charging Station; PowerUnit Handpiece; PowerUnit Motor Pack; PowerUnit Transfer Shield

Manufacturer; Complaint File Establishment

instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - FiberLocker Implant; FiberLocker Instrument; FiberLocker PowerUnit; FiberLocker PowerUnit Charging Station; FiberLocker PowerUnit Handpiece; FiberLocker PowerUnit Motor Pack; FiberLocker PowerUnit Transfer Shield; FiberLocker System; SpeedPatch PET

Manufacturer; Complaint File Establishment

mesh, surgical, non-absorbable, orthopaedics, reinforcement of tendon - FiberLocker Implant; FiberLocker Instrument; FiberLocker PowerUnit; FiberLocker PowerUnit Charging Station; FiberLocker PowerUnit Handpiece; FiberLocker PowerUnit Motor Pack; FiberLocker PowerUnit Transfer Shield; FiberLocker System; SpeedPatch PET

Manufacturer; Complaint File Establishment

Zurich Medical Inc

MN/USA

3013943846

2026

computer, diagnostic, programmable - Zurich Medical Accessory Cable; Zurich Pressure Guidewire System Model 100

Manufacturer

wire, guide, catheter - Zurich Medical Accessory Cable; Zurich Pressure Guidewire System Model 100

Manufacturer

computer, blood-pressure - Zurich Medical Accessory Cable; Zurich Pressure Guidewire System Model 100

Manufacturer

transducer, pressure, catheter tip - Zurich Medical Accessory Cable; Zurich Pressure Guidewire System Model 100

Manufacturer

accessory, surgical apparel - Zurich Face Shield

Manufacturer

ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI.

TURKEY

3036689755

2026

lenses, soft contact, daily wear - DAILIES AQUACOMFORT PLUS; DAILIES AQUACOMFORT PLUS MULTIFOCAL; DAILIES AQUACOMFORT PLUS TORIC

Foreign Exporter

lens, contact, (disposable) - DAILIES AQUACOMFORT PLUS; DAILIES AQUACOMFORT PLUS MULTIFOCAL; DAILIES AQUACOMFORT PLUS TORIC

Foreign Exporter

lenses, soft contact, daily wear - 1 Day Acuvue Define; 1 Day Acuvue Moist; 1 Day Acuvue Moist For Astigmatism; Acuvue 2; Acuvue Oasys Max 1-Day; ACUVUE OASYS MAX 1-Day MULTIFOCAL

Foreign Exporter

lenses, soft contact, daily wear - Biofinity Multifocal; Biofinity Toric; Biofinity; Biofinity Energys

Foreign Exporter

lenses, soft contact, daily wear - ACUVUE OASYS 1-Day with HydraLuxe; Acuvue Oasys For Astigmatism; Acuvue Oasys For Presbyopia; Acuvue Oasys Multifocal; ACUVUE OASYS with HydraLuxe

Foreign Exporter

Show all 28 Listings for ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI. TURKEY

ZUMAX MEDICAL CO, LTD.

CHINA

3006252153

2026

loupe, binocular, low power - DFK air Binocular Loupes; DFK Binocular Loupes; DFT Binocular Loupes; SLD Binocular Loupes; SLE Binocular Loupes; SLF Binocular Loupes; SLH Binocular Loupes; SLK Binocular Loupes; SLS Binocular Loupes; SLT Binocular Loupes; VARIOUS MODELS BINOCULAR LOUPES

Manufacturer

otoscope - OT8 series otoscopes; OT8C; OT8D; OT8DS; OT8F; OT8FS; OT8G; OT8GS; OT8H; OT8K; OT8V; OTOSCOPE

Contract Manufacturer; Manufacturer

light, surgical headlight - HEADLIGHTS; HL8000 HEADLIGHT; HL8200 HEADLIGHT; HL8260 HEADLIGHT; HL8300 HEADLIGHT; HL8350 HEADLIGHT

Manufacturer

microscope, surgical, general & plastic surgery - OMS1800 surgical microscope; OMS1950 surgical microscope; OMS2000 surgical microscope; OMS2030 surgical microscope; OMS2050 surgical microscope; OMS2300 surgical microscope; OMS2350 surgical microscope; OMS2355 surgical microscope; OMS2360 surgical microscope; OMS2365 surgical microscope; OMS2380 surgical microscope; OMS2650 surgical microscope; OMS2680 surgical microscope; OMS3000 Pro surgical microscope; OMS3000 surgical microscope; OMS3200 surgical microscope; OMS3200Pro surgical microscope; OMS3300 surgical microscope; OMS3500 Max surgical microscope; OMS3500 surgical microscope; OMS6000 surgical microscope

Manufacturer

retinoscope, battery-powered - DW3050; SR24 STREAK RETINOSCOPES; SR24A STREAK RETINOSCOPES; SR24B STREAK RETINOSCOPES

Manufacturer

Show all 20 Listings for ZUMAX MEDICAL CO, LTD. CHINA

ZUIKO MEDICAL CORPORATION

JAPAN

3012441818

2026

dressing, wound, occlusive - Plus moist TOP-W; Plus moist W

Manufacturer

tape and bandage, adhesive - Plus moist K; Plus moist SA-K

Manufacturer

dressing, wound, hydrophilic - Plus moist HS-W; Plus moist HSP; Plus moist HSP-W

Manufacturer

ZUGA MEDICAL, INC.

OH/USA

3010251542

2026

implant, endosseous, root-form - Zuga

Manufacturer

abutment, implant, dental, endosseous - Zuga

Manufacturer

accessories, implant, dental, endosseous - Zuga

Manufacturer

drill, dental, intraoral - Dental Drills for Zuga Dental Implant Systems

Manufacturer

bur, dental - Burs for Zuga Dental Implant Systems

Manufacturer

Show all 7 Listings for ZUGA MEDICAL, INC. OH/USA

ZUCKER'S GIFT INC

NY/USA

2438966

2026

ZUBLER USA, LLC

GA/USA

3010104363

2026

ZSQUARE LTD

ISRAEL

3023339162

2026

nasopharyngoscope (flexible or rigid) - Zsqaure ENT-Flex Endoscope

Manufacturer

ZSFAB INC

MA/USA

3022943642

2026

intervertebral fusion device with bone graft, cervical - ZSFab Cervical Interbody System

Specification Developer

intervertebral fusion device with bone graft, lumbar - ZSFab Lumbar Interbody System

Specification Developer

intervertebral fusion device with bone graft, cervical - ZSFab Cervical Interbody System

Specification Developer

intervertebral fusion device with bone graft, lumbar - ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System

Specification Developer

intervertebral fusion device with bone graft, cervical - ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System

Specification Developer

Show all 7 Listings for ZSFAB INC MA/USA

ZOUPURE MEDIC Co., Ltd.

THAILAND

3023191174

2026

polymer patient examination glove - Zoupure Glove

Manufacturer

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Establishment Registration & Device Listing

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