BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Karl Storz Endoscopy-America, Inc.

    Reg #: 3010202439 · FEI: 3007475226 · Expires 2026
    View on FDA
    Products
    220
    Proprietary Names
    559
    Establishment Types
    2
    Classifications
    220

    Registration Details

    Registration Name
    Karl Storz Endoscopy-America, Inc.
    Registration Number
    3010202439
    FEI Number
    3007475226
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2151 E. Grand Avenue
    City
    El Segundo
    State
    CA
    ZIP
    90245
    Country
    US

    Regulatory Submissions

    510(k) Number
    K940464
    PMA Number
    H040005

    Owner / Operator

    Firm Name
    KARL STORZ SE & CO KG
    Operator Number
    8010119
    Address
    Dr.-Karl-Storz-Strasse 34,
    City
    TUTTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    78532
    Country
    DE

    Products

    Device Name Product Code
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Endoscope, Neurological GWG
    Confocal Optical Imaging OWN
    Source, Carrier, Fiberoptic Light EQH
    Culdoscope (And Accessories) HEW
    Lithotriptor, Biliary Mechanical LQC
    Laparoscope, General & Plastic Surgery GCJ
    Bottle, Collection, Vacuum KDQ
    Speculum, Vaginal, Metal, Fiberoptic HDG
    Screw, Fixation, Bone HWC
    Arthroscope HRX
    Laparoscope, Gynecologic (And Accessories) HET
    Camera, Television, Endoscopic, Without Audio FWF
    Drape, Surgical, Exempt PUI
    Bur, Ear, Nose And Throat EQJ
    Light, Surgical, Accessories FTA
    Lithotriptor, Ultrasonic FEO
    Mirror, Ent KAI
    Dilator, Catheter GCC
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Attachment, Teaching, For Endoscope FEA
    Holder, Ear Speculum JYK
    Insufflator, Laparoscopic HIF
    Basin For Endoscope Reprocessing PHT
    Lithotriptor, Electro-Hydraulic FFK
    Cystourethroscope FBO
    Obturator, For Endoscope FEC
    Trocar, Gastro-Urology FBQ
    Endoscopic Contamination Prevention Sheath ODB
    Urethrotome EZO
    Table, Operating-Room, Electrical GDC
    Laryngoscope, Non-Rigid CAL
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Camera, Ophthalmic, Ac-Powered HKI
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    System, Digital Image Communications, Radiological LMD
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Esophagoscope (Flexible Or Rigid) EOX
    Bronchoscope (Flexible Or Rigid) EOQ
    Otoscope ERA
    Endoscopic Irrigation/Suction System OCX
    System, Irrigation, Urological LJH
    Insufflator, Hysteroscopic HIG
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    System, Image Processing, Radiological LLZ
    Hysteroscope (And Accessories) HIH
    Kit, Nephroscope FGA
    Light Source, Photographic, Fiberoptic FCR
    Image, Illumination, Fiberoptic, For Endoscope FFS
    Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
    Endoscopic Central Control Unit ODA
    Endoscope Holder OCV
    Fork, Tuning GWX
    Knife, Nasal KAS
    Clamp, Line FKK
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Retractor, Ophthalmic HNI
    Cannula And Trocar, Suprapubic, Non-Disposable FBM
    Mediastinoscope, Surgical EWY
    Endoscope, Rigid GCM
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Colonoscope And Accessories, Flexible/Rigid FDF
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    Cover, Barrier, Protective MMP
    Forceps, Biopsy, Non-Electric FCL
    Chair And Table, Medical KMN
    Accessories, Blood Circuit, Hemodialysis KOC
    Powered Laser Surgical Instrument GEX
    Neurological Stereotaxic Instrument HAW
    Light, Headband, Surgical FSR
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Brush, Dermabrasion, Manual GED
    Catheter And Tip, Suction JOL
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Tray, Surgical, Instrument FSM
    Knife, Ent KTG
    Clamp, Vascular DXC
    Resectoscope FJL
    Electrode, Electrosurgical, Active, Urological FAS
    Resectoscope, Working Element FDC
    Curette HTF
    Motor, Surgical Instrument, Ac-Powered GEY
    Insufflator, Endoscopic Vessel Harvesting OSV
    Mallet, Surgical, General & Plastic Surgery GFJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Ent Manual Surgical LRC
    Needle, Aspiration And Injection, Reusable GDM
    Camera, Television, Surgical, With Audio FWC
    Accessories, Arthroscopic NBH
    Amnioscope, Transabdominal (Fetoscope) (And Accessories) HFA
    Replacement, Ossicular Prosthesis, Total ETA
    Prosthesis, Partial Ossicular Replacement ETB
    Bougie, Esophageal, Ent KCD
    Dissector, Surgical, General & Plastic Surgery GDI
    Catheter, Drainage, Intraoral/Extraoral OAJ
    Drape, Microscope, Ophthalmic HMW
    Airway Suction Kit OFO
    Bulb, Inflation, For Endoscope FCY
    Splint, Nasal EPP
    Forceps, Wire Closure, Ent, Non-Sterile NNQ
    Container, Liquid Medication, Graduated KYW
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Bougie, Urological FAX
    Dilator, Urethral, Mechanical FAH
    Dilator, Urethral KOE
    Dilator, Catheter, Ureteral EZN
    Instrument, Surgical, Non-Powered HAO
    Operating Room Accessories Table Tray FWZ
    Dislodger, Stone, Biliary LQR
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Angioscope LYK
    Instrument, Manual, Surgical, General Use MDM
    Bottle, Collection And Trap, Breathing System (Uncalibrated) CBC
    Light, Surgical Headlight EBA
    Scalpel, One-Piece GDX
    Forceps, Biopsy, Gynecological HFB
    Cannula, Surgical, General & Plastic Surgery GEA
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Blower, Powder, Ent KCL
    Light Source, Fiberoptic, Routine FCW
    Led Light Source NTN
    Elevator HTE
    Probe, Ent KAK
    Tubing, Noninvasive GAZ
    Evacuator, Gastro-Urology KQT
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Pump, Air, Non-Manual, For Endoscope FEQ
    Accessories, Catheter, G-U KNY
    Instruments, Surgical, Cardiovascular DWS
    Attachment, Eyepiece, For Insertion Of Prescription Lens FDZ
    Transilluminator, Fiber Optic MQW
    Light Source, Endoscope, Xenon Arc GCT
    Endoscope, Fetal Blood Sampling (And Accessories) HGK
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Endoscopic Tissue Approximation Device OCW
    Yoke Assembly, Medical Gas CAM
    Saw, Surgical, Ent (Electric Or Pneumatic) EWQ
    Knife, Surgical EMF
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Instrument, Microsurgical GZX
    Curette, Uterine HCY
    Withdrawal/Infusion Pump DQI
    Gag, Mouth KBN
    Elevator, Ent KAD
    Light, Examination, Medical, Battery Powered KYT
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS
    Accessories, Cleaning Brushes, For Endoscope MNL
    Camera, Still, Endoscopic FXM
    Light, Catheter, Fiberoptic, Glass, Ureteral FCS
    Unit, Operative Dental EIA
    Forceps, Tube Introduction BWB
    Orthopedic Manual Surgical Instrument LXH
    Microscope, Surgical EPT
    Catheter, Balloon Type GBA
    Filler, Bone Void, Calcium Compound MQV
    Catheter, Irrigation GBX
    Tubing And Tubing/Filter Fits NVT
    Forceps, General & Plastic Surgery GEN
    Tube, Smoke Removal, Endoscopic FCZ
    Tubing, Pressure And Accessories BYX
    Tube, Aspirating, Flexible, Connecting BYY
    Laryngoscope, Nasopharyngoscope EQN
    Mask, Gas, Anesthetic BSJ
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Instrument, Special Lens, For Endoscope FEI
    Urethroscope FGC
    Proctoscope GCF
    Instruments, Dental Hand DZN
    Laryngoscope, Rigid CCW
    Forceps, Ent KAE
    Stylet, Surgical, General & Plastic Surgery GAH
    Hysteroscope Accessories NWW
    Stylet, Tracheal Tube BSR
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Catheters, Suction, Tracheobronchial BSY
    Vaginoscope And Accessories MOK
    Bur, Surgical, General & Plastic Surgery GFF
    Dislodger, Stone, Flexible FGO
    Syringe, Irrigating (Non Dental) KYZ
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Hook, Microsurgical Ear JYL
    Accessory, Surgical Apparel LYU
    Holder, Needle, Gastroenterologic FHQ
    Light, Surgical, Carrier FSZ
    Telescope, Laryngeal-Bronchial ENZ
    Punch, Nasal KAY
    Laryngoscope, Endoscope GCI
    Electrocautery, Gynecologic (And Accessories) HGI
    Retractor GAD
    Evacuator, Bladder, Manually Operated FFD
    Irrigator, Powered Nasal KMA
    Electrode, Electrosurgical JOS
    Speculum, Ent EPY
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Dilator, Vaginal HDX
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Forceps, Biopsy, Electric KGE
    Snare, Flexible FDI
    Retractor, Ent KAL
    Retractor, Self-Retaining, For Neurosurgery GZT
    Gastroscope And Accessories, Flexible/Rigid FDS
    Laryngostroboscope EQL
    Headlamp, Operating, Battery-Operated HPP
    Camera, Cine, Endoscopic, With Audio FTS
    Tube, Tracheal (W/Wo Connector) BTR
    Speculum, Illuminated FXF
    Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use PYO
    Light Source System, Diagnostic Endoscopic OAY
    Endoscopic Bite Block MNK
    Microscope, Surgical, General & Plastic Surgery FSO

    Proprietary Names

    URETERO-RENOSCOPES/URETEROSCOPE RHINO-PHARYNGO-LARYNGO FIBERSCOPE KARL STORZ ICG System KARL STORZ FIBEROPTIC Rigid Culdoscope and Accessories Lithotripter 3D Endoscope Vacusafe Vacuum Cannister and Bottles KARL STORZ VAGINAL SPECULUM MegaFix Bioabsorbable Screw Laproscopy ARTHROPUMP Plus DCI Endoscope Thoracic Surgery Instruments Retractors,Probes,Dissectors,Hooks MVM 7.5 French Flex. URETEROSCOPE FLEX-X2 Puncture Cannula KARL STORZ ENDOVISION HYSTEROCAM KARL STORZ ENDOVISION UROCAM KARL STORZ HYSTEROCAM Cover TAMBERGER-SACHASE INTRANASAL DRILL Laparoscope Contact Nasal Micro-Endoscope SCB/STERIS OR-Light Interface Box Model 27086C Ultrasonic LITHOTRITE MIrror Balloon Catheter UNIDRIVE II Plus Disposable Tubing FRIMBERGER Varioguide KARL STORZ ENDOSCOPE TEACHING ATTACHMENT HARTMANN Ear Speculum CO2 Endoflator Basin for endoscope reprocessing C-Cam Take-Apart Forceps CALCUTRIPT Elctrohydraulc LITHR SYS Flexible CMOS Video-Cysto Urethroscope Endoscopy Instrument KARL STORZ Fiber Telescopes for Urology CMOS Video Rhino Laryngoscope Cold Knife Series 11274 Flex. URETEROSCOPE DCI VIDEO LARYNGOSCOPE KARL STORZ suction and irrigation system Camera, ophthalmic, ac-powered SCB Media Control NEO NEO IP HD-View CALCUSPLIT Needles Endomat Select (Model Number: UP210) AUTOCON II 200 Electrosurg Generat KARL STORZ UDEL Sterilization Trays Endoscopic guidewire, gastroenterology-urology UROPUMP Disposable Tubing Set Intubation Fiberscope Sterilization Tray KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) AIDA w/ DICOM and HL7 Interface HAMOU ENDOMAT Disposable Tubing Set STEINER ELECTROMECHANIC MORCELLATOR ENDOPYELOTOMY Set Xenon Light Source/Flash UNIMAT Suction Pump Bipolar Electrodes SCB/CONMED ESU INTERFACE MODULE KS Lock Tuning Fork KNIFE, CURVED Clamp Image1 S CCU, Image1 S 4U camera head SCB-RUI (Realistic User Interface) KARL STORZ ICG Imaging System Endoscope Accessory Insulated Biopsy Forceps Blepharoplasty Set Cannula and Trocar HD Mediastinoscope SCB/Covidien Force Triad Interface Module Plastic Surgery Accessories 12G-SDI CABLE, Suction/Irrigation Tubes Fluid Light Cables KARL STORZ DE LA PLA CO2 HYDROMAT Pump for Irrigation Instruments, Bipolar Coagulation KARL STORZ Endoscopic ICG Imaging System STAMMBERGER SACSHE Drill Miniature Telescope and Accessories MTP Disposable Trocar Valves 26025UC HAMOU Elctrnc HYSTEROFLATOR KARL STORZ VIDEO LOWER Video Lower G.I. Endoscope System Disposable Equipment Covers Nasopharyngoscope Grasping, Biopsy, and Spoon Forceps Chair and Table, Medical Bronchoscope Insulated Dissecting Cannulae Optical Mediastinoscope Modified Veress Needle & Cannula ENDOMAT DISP, Tubing Sets KARL STORZ Urological Laser Accessories Navigation Panel Unit CLICKLINE Scissors Inserts for single use Cholangiography Set Fascia Closer Device Headband Headlight Telescpes, Rigid/Mgnifying/KS VARIA CCL Vaginal Extractor and Acc's Endomat Select ARTHROSCOPE Sunction Tube UROMAT 11274AC Flex. CHOLEDOCHOSCOPE TIPCAM 1S 3D System MTP Disposable Trocars Stone Basket CHARDONNES Morcellation Knife Endoscopic Assisted Intubation Set KARL STORZ HOPKINS Telescopes Laproscopy Insstruments Flexible Video-urethro-cystoscope KARL STORZ FLEXIBLE VIDEO- Esophagoscope Electronic LAPAROFLATOR MONOPOLAR VAPORIZATION Electrodes Bronchoscopes Instrument Tray EQUIMAT Model 203020 20 Unidrive SIII ENT KNIFE, ENT VISCOUS Fluid Injection Set Deployable Cardiovascular Clamp Neuroscope and Accessories Bipolar Coagulation Electrodes KARL STORZ Bipolar Resectoscopes with HF Cable CURETTE SACHSE DRILL Puncture, Injction, ENDOSCPIC VERES Flexible HD Cysto-Urethroscope System ENT/NEURO/OMF System and Accessory ENDOFLATOR + Mallet UNIMAT 45 KARL STORZ MODEL 28200C KSEA CLEARVISION II, MODEL 40334120 ENT Forceps, Scissors, and Punches Flexible HD Video Rhino-Laryngoscope System KARL STORZ REUSABLE ASPIR SEMM Tissue Punch Nephroscope, Adult & Pediatric Nasopharyngo/Broncho/Tracheoscopes 495N Series Fibr Optic Light Cables KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S Large Joint Arthroscopy Set OR1 IP Camera Arthroforce SilCut Shoulder Pro SilGrasp Fetoscopy Set Ped VANCAILLIE Take Apart Bip Instr Telescopes Holders Laproscope MULTIDRIVE II Mini Shaver Vein Discission Snares Cutting Loop Elctrodes Modification FISCH Titanium Mid Ear Prostheses FISCH TITANIUM MID Telepack X LED Micro-Instrum. for Cochlear Implant CALCULASE HOLMIUM LASE CALCULASE Holmium Laser & Acc. CALCULASE HOLMIUM LASER Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories GAAB Rigid NEUROENDOSCOPES KARL STORZ BOUGIES Miniature Neuro Endoscope KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE KARL STORZ Flexible Video-Neuro-Endoscope System C-MOUNT ARTHROSCOPE Micro-ARTHROPLSTY Sys. Disp. Blade Dissector Surgeon Connect Spinoscope CANNULA, OBTURATOR, VERESS NEEDLE Electronic LAPAROFLATOR (20 LPM) Balloon Cathether Drape KARL STORZ OTOSCOPE OTOSCOPE TIPCAM1 Rubina Video Endoscope System UROMAT E.A.S.I Adaptors for Documentation VOICE1 SCB R-UI Speech Control App Suction Tube Sterilization Trays Insufflation Bulb Instr, TX of Carpal Tunnel Syndrome MANHES Pneumotrocar DION-GRACIA Set Nasal Splint Karl Storz Arthropump Power Irrigation/Suction Pump, Tubing Wire Crimper Wound Closure Instruments UNIDRIVE II/II Plus & ENT Accessori Medicine Cups S-Pilot Endoscopy Powder Blower Ureteroscope and accessories, flexible/rigid DCI Telescope Insulated Scissors & Rectal Snares Wiltek Grasping Forceps BOUGIES and Dilators Transvaginal Endoscopy Set Endoscope MTP Extraction Bags Nonpowered neurosurgical instrument Semi-rigid Hysteroscope Suction Catheters KARL STORZ LEG HOLDER LEG HOLDER KARL STORZ SHOULDER ARTHROSCOPY POS KARL STORZ FORCEPS EPIDUROSCOPE KARL STORZ BOUGIE Knives,Curettes,Hooks,Needles Unidrive Shaver ARTHROSCOPY Blades Insulated Scissors Take Apart Rotating Grasping Forcep XR-MX X-Ray System Vascular Fiberscopes STEINER Electromechanic Morcellator Rigid Telescopes IMAGE1 General/Plastic Surgery Instruments manual surgical instrument ENT Semi-Rigid Micro-Endoscpes & Acc. SINGLE-USE TISSUE TRAP FILTER W/ADAPTER KOH Needle Holders, Suture Forceps SCBCOM Autocon II 400 Electrosurgical Gen HYDROMAT, Model 263110 20 Flexible Video Cysto-Urethroscope UNIMAT 12 Pressure Cuff Twin-Video KARL STORZ BIOPSY FORCEPS Ureter Resectoscope ENDOTIP System KARL STORZ SURGICAL CANNULA BETTOHI SNARE Trans-Nasal Esophagoscopes UROMAT Disposable Tubing Set KARL STORZ HOPKINS Telescopes for Urology Cotton Applicator MVM 3.3 MM MICROENDOSCOPE Powder Blower and Accessories Power LED 175 Camera Telepack + Modification to ENDOTIP System Whisker Arthroscopic Blade Fiberscope ELEVATOR SCB Interface Control #20090120 Image Processing System UNIMAT Plus Series 11274 Flexible Fiberscope Slim Nasopharyngolaryngoscope Hand Extractor HECTOR Endoscope Accessories Model 27080 LITHOTRIPTOR System MegaFix-T Titanium Screw Nasal Probe 2800C Shouldr/Ankle/Elbw/Hip/TMJ/SM HAMOU ENDOMAT Continuous Flow RESECTOSCOPES Miniature Telescope for Urology HUZLY High Freq Cutting Loops Obstetrical and Gynecological Surgical Devices KARL STORZ Mediastinoscopes and Instruments VACUSAFE TUBING SETS Vaporization Electrodes Suction/Drainage Tubes, Cannulae Hysteromat II Extraction Bag Bridges, Adaptors MVM 7.5 French Flex. HYSTEROSCOPE Video Flexible ENT Endoscope System HOPKINS Telescopes MTP LAPAROMAT Disposable Tubing Set Magnifying Telescopes Pivot Arm PAPARASCOPE Sleeve GI CCU Tubing with Connector CO2mbi LED SCB Catheters, MANDRIN, Plugs, Connect ENT Stent Applicator Forceps ENDOMAT LC PUMP Resectoscopes RETRACTOR TRACHEAL RESECTOSCOPE 300W Light Source, Non-flash EYEPIECE ATTACHMENT FOR INS AIDA Compact II System ADVANCED IMAGE AND DATA Trocars, Cannulae and Sheaths Twin Transilluminator TELESCRUB Xenon Light Source (175W) 201320-20 Flexible CHOLEDOCHOSCOPE Scalp Blood Collection Set Arthroscopic Telescopes CMOS Endoscopes SSU LED light source Adult/Pede VISCOUS Fluid Inject.Set Distending DIVERTICULOSCOPE KARL STORZ Cholangiography Set KOH Micro-Suturing Instruments KARL STORZ MEDICAL Cold Knife Blades Power LED 175 Light Fountain Light Fountain 50 Watts KARL STORZ Ped. Cysto-Urethro-Fiberscope Scissors, ENDO/LAP FELDMAN Mini-saw Reinsertion Forceps Continuous Flow Cystoscope Flex. HYSTEROSCOPE Forceps, ENDO/LAP Bipolar Electrotome Micro-ARTHROPLASTY System KOH Needle Holders, Suturing Forcep AUTOCON II 400 Electrosurgical Gen. MTP ARTHROUMP TUBING SET KARL STORZ SURGICAL KNIFE Mono Coag Needle Electrode Surgical Instruments Contact Microlaryngoscope Neuro-Fiberscope Micro Surgical Instruments Mono Vaporization Electrodes Flexible Trocar Sleeves UROMAT for Urological Irrigation KARL STORZ CURETTES QUADROSWITCH Telescopes, Rigid/Magnifying ARTHROPUMP Disposable Tubing Set ANGIOMAT, Model 383320 20 Elec Endoflator, Model 264305 20 Monopolr Cord, Endoscpc Hi-Frequncy MOUTH GAG ENT Elevators Flexible Video-Uretero-Renoscope Flex-XC Battry Powered Light Source Pede PYLORIC Spreader, PYLOROTOME Laryngoscope Accessories SCB/VALLEY LAB Force FX Interface Storz SLX-F2 Storm Touch Obturators, Cannula Sheaths Operating LARYNGOSCOPES & Accs Endotack Cleaning Brushes and kits Reverse Video Drill KARL STORZ ENDOSCOPIC STILL CAMERA Light Cable Image 1 SPIES Dental Endoscopes Uterine Manipulator Forceps Ortho Manual Surgical Instruments Microcast HD Pro Microcast 4K Pro VITOM H1 Camera Head Fiber Optic Light Cables GELET Uretero-Renoscope Laser Accessories Rotocut G1 Morcellator, Electromech Syntricer Synthacer Electronic LAPAROFLATOR (10 LPM) Cystoscope 78FAJ, Fiberoptic 78GDB ERCP CATHETER Prism ELECTROSCOPE Xenon Nova Light Source HD View HYSTEROSCOPIC INSU Telescope Bridges & Adaptors Device Imaging Storage Smoke Removal Tube KARL STORZ PRESSURE T KARL STORZ FLEXIBLE ASPIRATING TUBE Dilators, Reducers, Sleeves Flexible Hysteroscope, 10.5 Fr KARL STORZ Laryngoscopes and Accessories Flexible Intubation Video Endoscope – Sterile (FIVE-S) Gas Mask REMORGIDA Forceps SSU Flexible Video-Uretero-Renoscope OR1 SCB CONTROL KARL STORZ ENDOSCOPE LENS ENDO-MAGNIFIER Plastic Trocars Miniature Endoscope Esophagoscope and Accessories Semi-Rigid Microendoscope & Acc. Protoscopes, Sigmoidoscopes, Acc. Dental Hand Instruments Knives,Curettes,Hooks,Probes UNIMAT Plus, Model 203210 01 KARL STORZ LARYNGOSCOPE Optical Video Tongue Depressor MAHNES Take-Apart Bipol Coag Forcep UNIDRIVE SIII System Mono Ball/Needle/Loop Electrodes UROPUMP Fiber and Sheath Mono Coag Needle, Loop Electrodes New Generation Trocars SCB ACC CONTROL (AND OTHERS) FORCEPS, EAR HOPKINS I/II Autoclavable Telescope KARL STORZ Pediatric Cysto-Urethro-Fiberscope Take Apart Suture Forceps SAUER Endscpc Guide & Intbation Aid Instr Set Percut Discect/Nucleotomy KARL STORZ SURGICAL STYLET Hysteroscope and accessories CMOS Video-Rhino-Laryngoscope System Tracheal tube Percutaneous Foraminoscopy Set MTP Suction canisters/tubing Suction Catheter KARL STORZ ICG Imaging System with RUBINA Lens System Medi Pack Infant Balloon VAGINOSCOPES Knives, Curettes Endoscope Holder MegaFix Perforated Bioabsorbable LAPAROMAT Laparoscopic Suction SUBGLOTTISCOPE, Infant & Neonate THERMOFLATOR, Model 26 4320 20 Take-Apart Scissors Model 26021C Bipolar COAGULATOR Insulated ELECTROSUGRICAL Instrum. KARL STORZ STONE DISLODGER SYRINGE, IRRIGATING (NON DENTAL) Semi-Rigid Micro-Endoscpes & Acces. NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) MVM 3.3 MM Micro-Endoscope N20 ENDOFLATOR Hysteroscope Endoflator LC Powershaver System S2 Model28184 Pneumatic Shuttle Shaver ENT Surgical Instrument Zero Wire EQUIMAT, Model 203020 20 Rhino-Laryngo-Bronco Fiberscope Microsurgical Ear UNIDRIVE S III ENT CLEARVISION Lens Irrigation System KSEA CLEARVISION LE Intra-Handpieces & Accessories SPIES 3D System Drapery KARL STORZ NEEDLE HOLDERS MTP CLEARVISION Disp Tubing Set KARL STORZ Shuntscope Surgical Light Carrier KARL STORZ Image1 S Camera Control Unit 11274AB Flex Pediatric BRONCHOSCOPE Telescopes, Rigid, HOPKINS I ENDOFLATOR 40&50 ENT Rigid Telescopes PUNCH, NASAL Mono High Freq Cords SAWAHLE Electromech. Morcellator Sialoendoscopes and Accessories LAPAROCAM 3D Video System Model 27224P Continuous Flow Pump Thermocoagulator, Model 26510020 PT Coagulator, SEMM Crocodile Force Tissue Retractor Bipolar Coagulating Forceps SCB-RUI SCO KARL STORZ BLADDER EVACUATOR Nasal Irrigator Catheters Culdocentesis Set Ablation Electrodes XENON NOPPVA Take-Apart Bipolar Forceps Neuro FIBERSCOPE KSEA Monopolar Resectoscopes Speculum, ENT KARL STORZ NAV1 Electromagnetic Navigation System Flexible Video-Uretero-Choledochoscope-System DIGI-VIDEO Model 28805 ARTHRO Pump ENDOSCOPE ACCESSORIES NeoVagina Surgery Set & Accessories KARL STORZ FELDMAN MIN ARTHRO PUMP Carcinoma Gauges TUBING SET FOR LAPAROSCOPIC INSUFFL TUBING Insulated Cannulae & Suction Tubes Monopolar Coagulating Electrodes Insulated Biopsy Forceps, Grasping Flexible Choledochoscope Percutaneous Nephroscope System CO2 ARTHROFLATOR AUTOCON III 400 Telescope Bridges/Inserts/Adaptors UNIMAT, Model 203200 20 Karl Storz Scalp Dura Retractor HYDROMAT Trumpet Valve & Tubing Set Saphenous Vein Harvesting Set ARTHROPUMP DISP, Tubing Set KARL STORZ VIDEO GASTROSCOPES Video Gastroscopes LED NOVA 100 Cold Light Fountain KARL STORZ Cysto-Urethro-Fiberscope KARL STORZ Endoscopic Accessories for Urology Irrigation/Suction Sys/Handpiece KARL STORZ PULSAR II Targeting Unit Mono Coag Ball Electrodes Karl Storz MegaFix-C Composite Ped VANCAILLIE MANHES Take Apart LED Headlight KS70 Xenon 100 HEMPFLING Dilation Set Calculase II Powered Laser Surgical Instrument 7.5 Fr. Flexible CHOLEDOSCHOSCOPE Non-Insulated Scissors Trachea Tubes OP Server Lap Speculum Tape and bandage, adhesive, adjustable closing mechanism, OTC use ENDOSPINE Oper Tube & Telesc Bridge CALCUSON Light source system, diagnostic endoscopic BITE PROTECTORS Surgical Microscope

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility