MED2B LTD.

FDA Device Registration & Listing · Kitzingen Bavaria, DE · Registration 3035708926

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035708926
FEI Number
3035708926
Entity Name
MED2B LTD.
City/State/Country
Kitzingen Bavaria, DE
Establishment Address
Lochweg 2A, Kitzingen Bavaria 97318, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Med2B Ltd. (Owner Number: 10092562)
Owner / Operator Contact Address
Lochweg 2A, Kitzingen, DE-NOTA 97318, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

FORCEPS, BIOPSY, GYNECOLOGICAL SPECULUM, NON-ILLUMINATED RING CUTTER DEPRESSOR, TONGUE, NON-SURGICAL BRACE, DRILL CHISEL, NASAL CARVER, DENTAL AMALGAM, OPERATIVE BOUGIE, UROLOGICAL PLIER, ORTHODONTIC CUTTER, SURGICAL PLIERS, SURGICAL INSTRUMENT, LIGATURE PASSING AND KNOT TYING Applier, staple, surgical Biopsy Grasping Forceps, teethed, sharp spoon D 2mm, WL 330mm Biopsy Grasping Forceps teethed spoon D 2.5mm, WL 260mm Biopsy Grasping Forceps teethed spoon D 2mm, WL 330mm Biopsy Grasping Forceps, teethed, sharp spoon D 3.5mm, WL 330mm Biopsy Grasping Forceps toothed, sharp spoon, Jaw upward D2mm, WL 330mm BLAKESLEY Biopsy Grasping Forceps D 2.5mm, WL 330mm Biopsy Grasping Forceps, teethed, sharp spoon D 3mm, WL 260mm Biopsy Grasping Forceps teethed spoon D 2mm, WL 260mm Biopsy Grasping Forceps, teethed, sharp spoon D 2.5mm, WL 260mm Biopsy Grasping Forceps teethed spoon D 3mm, WL 330mm FORCEPS, BIOPSY, NON-ELECTRIC Biopsy Grasping Forceps teethed spoon D 3.5mm, WL 330mm Biopsy Grasping Forceps teethed spoon D 4mm, WL 330mm Biopsy Grasping Forceps teethed spoon D 4mm, WL 260mm BLAKESLEY Biopsy Grasping Forceps D 2.5mm, WL 260mm BLAKESLEY Biopsy Grasping Forceps D 3.5mm, WL 260mm Biopsy Grasping Forceps toothed, sharp spoon, Jaw upward D2mm, WL 260mm Biopsy Grasping Forceps, teethed, sharp spoon D 4mm, WL 260mm Biopsy Grasping Forceps, teethed, sharp spoon D 2.5mm, WL 330mm Biopsy Grasping Forceps, teethed, sharp spoon D 3mm, WL 330mm Biopsy Grasping Forceps, teethed, sharp spoon D 4mm, WL 330mm Biopsy Grasping Forceps toothed, sharp spoon, Jaw upward D2.5mm, WL 330mm BLAKESLEY Biopsy Grasping Forceps D 3.5mm, WL 330mm Biopsy Grasping Forceps, teethed, sharp spoon D 2mm, WL 260mm Biopsy Grasping Forceps teethed spoon D 2.5mm, WL 330mm Biopsy Grasping Forceps teethed spoon D 3.5mm, WL 260mm Biopsy Grasping Forceps teethed spoon D 3mm, WL 260mm Biopsy Grasping Forceps, teethed, sharp spoon D 3.5mm, WL 260mm Biopsy Grasping Forceps toothed, sharp spoon, Jaw upward D2.5mm, WL 260mm Ophthalmoscope, ac-powered Goniometer, nonpowered CHISEL, MASTOID BLADE, SCALPEL GUILLOTINE, TONSIL FORCEPS, TOOTH EXTRACTOR, SURGICAL Cannula, ophthalmic ACCESSORIES, TRACTION Cannula and trocar, suprapubic, non-disposable SOUND, UTERINE Duck Jaw Punch Straight D 3.5mm, WL 260mm Hook Punch, O3,5mm, WL 330mm PUNCH, SURGICAL Scissors Punch Up Angled Jaw D 2.5mm, WL 330mm Scissors Punch Straight Jaw D 2mm, WL 260mm Scissors Punch Straight Jaw D 3mm, WL 260mm Scissors Punch Up Angled Jaw D 2.5mm, WL 260mm Scissors Punch Straight Jaw, O3,5mm, WL 260mm Duck Jaw Punch Straight D 3.5mm, WL 330mm Hook Punch, O3,5mm, WL 260mm Scissors Punch Straight Jaw D 2.5mm, WL 330mm Scissors Punch Straight Jaw D 3.5mm, WL 330mm Scissors Punch Straight Jaw D 2.5mm, WL 260mm INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Bone drill D 6.5mm, WL 250mm, cannulated Bone drill D 9mm, WL 250mm, cannulated Bone drill D 8mm, WL 250mm, cannulated Bone drill D 4.5mm, WL 250mm, cannulated PERCUSSOR TAPE, MEASURING, RULERS AND CALIPERS KNIFE, EAR Spine Tray TRAY, SURGICAL, INSTRUMENT FORCEPS, RONGEUR, SURGICAL SNARE, NASAL KNIFE, SURGICAL HOLDER, EAR SPECULUM Orthopedic manual surgical instrument Metal Hammer OD 30mm, WL 260mm Spine Hammer OD 25mm, WL 200mm HEMOSTAT URINAL FILIFORM AND FILIFORM FOLLOWER CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY HOOK, BONE HANDLE, SCALPEL Forceps, obstetrical FILE, PERIODONTIC CURETTE, NASAL SKID, BONE PROBE, RECTAL, NON-POWERED PUNCH, ANTRUM CLAMP, NON-ELECTRICAL Headlamp, operating, battery-operated ADENOTOME Amniotome SPLINT, HAND, AND COMPONENTS Knife, ophthalmic APPLICATOR, ABSORBENT TIPPED, NON-STERILE INSTRUMENT, CUTTING, OPERATIVE INSTRUMENT, ENT MANUAL SURGICAL SPECULUM, ENT BENDER TRACHEOTOME CANNULA, EAR CARRIER, AMALGAM, OPERATIVE INSTRUMENT, SURGICAL, NON-POWERED CURETTE, UTERINE PROBE AND DIRECTOR, GASTRO-UROLOGY Applier, surgical, clip Dilator Cervical ID2.3mm, OD2.8mm, WL 80mm Dilator Cervical ID3.2mm, OD4, WL 76mm Dilator Cervical ID1.2mm, OD2.2mm, WL 100mm DILATOR, CERVICAL, FIXED SIZE Dilator Cervical ID2.2mm, OD3 WL 97mm STRIPPER, SURGICAL INSTRUMENT, CUTTING, ORTHOPEDIC KNIFE, AMPUTATION Alligator Grasper Up Angled Jaw D 2.5mm, WL 330mm Micro Spoon Straight Jaw D 4mm, WL 330mm Grasping Forceps Straight Jaw D 2mm, WL 330mm FORCEPS Cup Forceps Straight Jaw D 3.5mm, WL 330mm Cup Forceps Straight Jaw D 2.5mm, WL 330mm Cupped Grasper Straight Jaw D 3.5mm, WL 260mm Grasping Forceps Straight Jaw D 4mm, WL 260mm Cupped Grasper Left Jaw D 2mm, WL 330mm Cup Forceps teeth Straight Jaw D 4mm, WL 260mm Cup Forceps Straight Jaw D 4mm, WL 330mm Cup Forceps Up Angled Jaw D 2.5mm, WL 330mm Micro Spoon Up Angled Jaw D 2.5mm, WL 260mm Alligator Grasper Straight Jaw D 2mm, WL 330mm Cup Forceps Straight Jaw D 3.5mm, WL 260mm Alligator Grasper Straight Jaw D 2mm, WL 260mm Grasping Forceps Straight Jaw D 4mm, WL 330mm Cup Forceps teeth Straight Jaw D 2.5mm, WL 260mm Micro Spoon Straight Jaw D 3.5mm, WL 260mm Cupped Grasper Right Jaw D 2mm, WL 330mm Micro Spoon Straight Jaw D 2.5mm, WL 330mm Micro Spoon Straight Jaw D 2.5mm, WL 260mm Cup Forceps Straight Jaw D 4mm, WL 260mm Cupped Grasper Straight Jaw D 4mm, WL 330mm Cup Forceps teeth Straight Jaw D 2mm, WL 260mm Cupped Grasper Straight Jaw, double action D 2mm, WL 260mm Cup Forceps Straight Jaw D 3mm, WL 330mm Grasping Forceps Straight Jaw D 3.5mm, WL 330mm Micro Spoon Straight Jaw D 4mm, WL 260mm Micro Spoon Up Angled Jaw D 2.5mm, WL 330mm Cup Forceps teeth Straight Jaw D 3.5mm, WL 260mm Micro Spoon Up Angled Jaw D 2mm, WL 330mm Micro Spoon Straight Jaw D 2mm, WL 330mm Cup Forceps teeth Angled Jaw D 2mm, WL 260mm Cup Forceps teeth Angled Jaw D 2.5mm, WL 260mm Cupped Grasper Straight Jaw D 4mm, WL 260mm Grasping Forceps Straight Jaw D 2.5mm, WL 330mm Cupped Grasper Straight Jaw D 2mm, WL 330mm Micro Spoon Straight Jaw D 3.5mm, WL 330mm Alligator Grasper Straight Jaw D 3.5mm, WL 330mm Cup Forceps Straight Jaw D 2.5mm, WL 260mm Cup Forceps Straight Jaw D 2mm, WL 260mm Cup Forceps Straight Jaw D 2mm, WL 330mm Cupped Grasper Straight Jaw D 3.5mm, WL 330mm Grasping Forceps Straight Jaw D 3.5mm, WL 260mm ACCESSORIES, CATHETER Caliper, ophthalmic RAZOR, SURGICAL HOLDER, NEEDLE; ORTHOPEDIC FILE PROBE, PERIODONTIC REAMER Pliers, operative LOOP, WIRE EXPLORER, OPERATIVE HOLDER, NEEDLE, GASTROENTEROLOGIC SPECULUM, RECTAL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE KNIFE, MARGIN FINISHING, OPERATIVE CURETTE HOOK, TONSIL SUTURING HOOK, MICROSURGICAL EAR FILE, BONE, SURGICAL APPLIER, HEMOSTATIC CLIP WRENCH SPOON, EAR CURETTE, EAR TUBE, EAR SUCTION Trephine cervical ID 2.7mm, OD 3.1mm, WL 180mm Trephine ID 4.5mm, OD 6mm, WL 220mm Trephine ID 6.5mm, OD 8mm, WL 220mm Trephine cervical ID 3.3mm, OD 3.7mm, WL 150mm Trephine cervical ID 1.2mm, OD 2.2mm, WL 101mm Trephine ID 2.55mm, OD 3.55mm, WL 350mm Trephine ID 4.1mm, OD 5.1mm, WL 225mm Trephine ID 3.1mm, OD 4.1mm, WL 350mm Trephine ID 5.6mm, OD 6.6mm, WL 225mm Trephine ID 6.6mm, OD 7.6mm, WL 225mm Trephine cervical ID 2.2mm, OD 3mm, WL 101mm Trephine ID 7.5mm, OD 9mm, WL 220mm Trephine cervical ID 1.2mm, OD 2.2mm, WL 99mm Trephine cervical ID 1.5mm, OD 2mm, WL 260mm Trephine ID 5.5mm, OD 7mm, WL 220mm Trephine cervical ID 2.2mm, OD 3mm, WL 96mm RONGEUR, MASTOID Curette, ophthalmic SNARE, TONSIL Punch, corneo-scleral PELVIMETER, EXTERNAL Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 0,7mm, gerade Bipolare Saugpinzette, bajonett Saugunterbrecher, 19/0814 SCHMAL Ohr u. Nasenpinzette Lucae, 14 cm SPI 1060510 Mikro Pinzette Titan blau SPI 1050915 Dentalpinz. 15 cm, 1 x 2 Z. 19/0611 Ohr u. Nasenpinzette Cottle, 11 cm Bipolar Meuser 18cm, Maul 2,0mm, lang abgewinkelt, mit Auflagestift Antihaft non stick Bipolar 19,5cm Maul 2,0mm, abgewinkelt Antihaft Bipolar 16,5cm kniegebogen, Maul spitz Bipolar 11cm, Maul 0,5mm, gerade ohne Stift Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 1,2mm, lang abgewink Antihaft Bajonett Bipolar 19,5cm Maul 0,3mm, gerade, 2 mm Spitze Antihaft Bajonett Bipolar 19,5cm Maul 2,0mm gerade Antihaft Bajonett Bipolar 23cm breiter Griff Maul 0,4mm m Stopp-Fuh. Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 1,2mm, gerade 13/9013 Allis Pinzette, 13 cm 19/1221 Ohr u. Nasenpinzette 21 cm 10/0620 Atrauma Pinzette DeBakey 20 cm, 13/0714 Chirurgische Pinzette, 14,5 cm 25/0019 Zungenspatel Bruenings, 19 cm 19/1219 Ohr u. Nasenpinzette 19 cm 13/0214 Chirurgische Pinzette, schmal, 14,5 cm 13/0220 Chirurgische Pinzette, schmal, 20 cm Antihaft non stick Bipolar 19,5cm Maul 0,5 gerade Antihaft Bajonett Bipolar 23cm breiter Griff, Maul spitz, gerade Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 2,0mm, gerade Antihaft Bajonett Bipolar 16cm Maul 1,0mm, gerade Non Stick Bipolar bajonett 17cm breiter Griff Maul 0,4 mm gerade Antihaft non stick Bipolar 19,5cm Maul 0,5mm, abgewinkelt Antihaft Bajonett Bipolar 25cm breiter Griff, Maul spitz, abwarts gew. 11/2018 Anat. Pinzette HM Taylor, 18 cm 13/2020 Chirurgische Pinzette, 12 cm 12/0220 anatomische Pinzette, schmal, 20 cm Bipolar TC Meuser 21 cm, Maul 3,2 mm 45 lang gebogen, breiter Griff 10/0616 Atrauma Pinzette DeBakey 16 cm 11/0020 Anat. Pinzette HM, standard, 20 cm 19/0213 Ohr u. Nasenpinzette, 13 cm 12/0020 anatomische Pinzette, standard, 20 cm Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 0,7mm, abwarts gew. Antihaft Bajonett Bipolar 19,5 cm Maul spitz, gerade Antihaft Bajonett Bipolar 19,5cm Maul 1,0mm, gerade Antihaft Bajonett Bipolar 20cm breiter Griff Maul 0,4mm mStopp-Fuhr. 17/0411 JuwelierPinzette Fig. 5, 11 cm 10/0220 Atrauma Pinzette DeBakey, 20 cm, SPI 1060310 Mikro Hakchen Titan Antihaft Bajonett Bipolar 19,5cm Maul 1,0mm gerade Antihaft non stick Bipolar 16cm Maul 0,5mm, abgewinkelt 13/0020 Chirurgische Pinzette standard 20 cm 19/0814 1,6MM Ohr u. Nasenpinzette Lucae, 14 cm 12/5212 anatomische Pinzette Adson, 12 cm 19/0015 Ohr u. Nasenpinzette, 15 cm 20/0007 Irispinzette Graefe, anat., 10 cm 12/5412 anatomische Pinzette, 12 cm Antihaft Bajonett Bipolar 16 cm Maul spitz, gerade Bipolare Pinzette, bajonett, Non-Stick 23 cm,Maul: 0,7mm-gerade Non Stick Bipolarpinzette, Rundgriff kniegebogen, nach oben gewinkelt 13/2213-07 Semken, chirurgisch, 12,5 cm 13/1212 Chirurgische Pinzette Adson, 12 cm 20/0607 Irispinzette Graefe, chir., 10 cm Non Stick Bipolar Pinzette 19,5 cm, Maul 0,7 mm, Non Stick Bipolar bajonett 17 cm breiter Griff Maul 0,4 mm gerade 19/1110 Hildmann Knorpelpinzette, gerade, 11 cm 20/0807 Irispinzette Graefe, chir., 10 cm 15/0615 Splitter Pinzette, glatt, 14,5 cm Bip. Akustikusneurinom Ringpinz 16cm45 n oben geb Ring 2,0mm x 1,0mm Bipolare Ring Pinzette, kniegebogen Antihaft Bajonett Bipolar 19,5 cm Maul 1,5 x 4 mm, lang aufwarts 22/0011 Fixierpinzette Graefe, 11 cm 131212 Chirurgische Pinzette Adson, 12 cm Non Stick Bipolarpinzette, Rundgriff kniegebogen, nach unten gewinkelt Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 1,2mm, aufwarts gew Antihaft Bajonett Bipolar 20cm breiter Griff Maul 0,4mm Antihaft Bajonett Bipolar 19,5cm Maul spitz aufwarts gewinkelt 10/1016 Atrauma Pinzette DeBakey 16 cm, 10/0816 Atrauma Pinzette DeBakey 16 cm, SPI 1050419 Ohr und Nasenpinzette, 11 cm 20/0207 Irispinzette Graefe, anat., 10 cm Antihaft Bajonett Bipolar 19,5cm Maul 2,0mm, aufwarts gewinkelt Non Stick Bipolar bajonett 23 cm breiter Griff Maul 0,4 mm gerade Antihaft Bajonett Bipolar 16cm Maul 0,5mm, gerade 19/0508 Ohr u. Nasenpinzette Cottle, 8 cm SPI 1049815 Wullstein Pinzette, anatomisch 19/1014 Ohr u. Nasenpinzette Lucae, 14 cm Antihaft Bajonett Bipolar 19,5cm Maul 0,5mm, gerade, 2 mm Spitze 19/1216 Ohr u. Nasenpinzette 16 cm SPI 1050815 Dentalpinz. 15 cm, gerieft, Antihaft non stick Bipolar 16cm Maul 2,0mm, abgewinkelt Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 2,0mm, aufwarts gew. SPI 1060410 Mikro-Hakchen Titan Antihaft Bajonett Bipolar 25cm breiter Griff, Maul spitz, aufwarts gew. Antihaft Bajonett Bipolar 23cm breiter Griff, Maul 0,4mm, Antihaft Bajonett Bipolar 25cm breiter Griff, Maul spitz, gerade 19/0017 Ohr u. Nasenpinzette, 17 cm 13/0218 Chirurgische Pinzette, schmal, 18 cm Antihaft non stick Bipolar 19,5cm Maul 1,0mm, gerade Non Stick Bipolar bajonett 25 cm breiter Griff Maul 0,4 mm gerade SPI 2072014 Cottle Nasenpinzette, bajonett Non Stick Bipolar bajonett 20 cm breiter Griff, Maul 0,4 mm gerade Antihaft Bajonett Bipolar 19,5cm Maul 1,5mm, gerade, 2 mm Spitze Bipolar 11cm, Maul 0,5mm, abgewinkelt ohne Stift 11/2020 Anat. Pinzette HM Taylor, 20 cm 13/0014 Chirurgische Pinzette standard 14,5 cm 12/0214 anatomische Pinzette, schmal, 14,5 cm SPI 1060000 Nadel aus Titan Non-Stick Bipolar, bajonett,23 cm breiter Griff, Maul 0,7 mm gerade Antihaft Bajonett Bipolar 19,5cm Maul 2,0mm, gerade Antihaft Bajonett Bipolar 23cm breiter Griff Maul 0,4mm m Stopp F. 20/3809 Irispinzette Bishop Harmon, 8,5 cm 13/9020 Allis Pinzette, 20 cm Antihaft non stick Bipolar 25cm Maul 1,0mm, abgewinkelt Antihaft non stick Bipolar 16cm Maul 1,0mm, abgewinkelt Antihaft Bajonett Bipolar 19,5cm Maul 0,5 mm, gerade Non Stick Bipolar bajonett 17cm breiter Griff Maul 0,7 mm gerade Antihaft Bajonett Bipolar 19,5cm Maul 0,5mm, gerade Antihaft non stick Bipolar 22cm Maul 1,0mm, gerade 11/0612 Chir. Pinzette HM Adson 12 cm 13 0218 Chirurgische Pinzette, schmal, 18 cm 11/0412 Anat. Pinzette HM Adson, 12 cm SPI 1060100 Mikro Nadel aus Titan 13/0018 Chirurgische Pinzette standard 18 cm SPI 1051215 Einfuhrpinzette gewinkelt, Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 1,2mm, abwarts gew. 11/0812 Chir. Pinzette HM Adson-Brown, 12 cm 13/9018 Allis Pinzette, 18 cm Antihaft bipolare Pinzette, NON-Stick, Troeltsch,ohne Fuhrungsstift, 14cm, Antihaft non stick Bipolar 16cm Maul 0,5mm, gerade Zimmermann Akustikusneurinom TROELTSCH Ringpinz. 80 n. oben geb kniegebogen Non Stick Bipolar Pinzette 16 cm, Maul 1,2 mm, lang Antihaft non stick Bipolar 16cm Maul 1,0mm, gerade 19/0011 Ohr u. Nasenpinzette, 11 cm 19/1416 Ohr u. Nasenpinzette 16 cm 13/3015 Chirurgische Pinzette, 15 cm 13/0716 Chirurgische Pinzette, 15,5 cm SPI 1048915 Pinzette Helms 15cm Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 0,7mm, aufwarts gew. Bip Akustikusneurinom Ringpinz16cm 70 80 n. oben geb Ring 1,0mm x 0,5mm 13/1612 Chirurgische Pinzette, 12 cm 13/0412 Chirurgische Pinzette, fein, 11,5 cm 12/0014 anatomische Pinzette, standard, 14,5 cm Antihaft non stick Bipolar 19,5cm Maul 2,0mm, gerade Bipolar 11 cm, Maul 1,0mm, abgewinkelt ohne Stift 13/2215 Chirurgische Pinzette, 15,5 cm 19/0013 Ohr u. Nasenpinzette, 13 cm 19/0814 Ohr u. Nasenpinzette Lucae, 14 cm Non-Stick Bipolar bajonett 20cm breiter Griff Maul 0,7 mm gerade Antihaft non stick Bipolare Pinzette 26 cm, Maul 2,0mm, gerade, breiter Griff 12/0030 anatomische Pinzetten, standard, 30 cm SPI 1049915 Wullstein Pinzette, chirurg 1 x 2 Z. 20/4009 Irispinzette Bishop Harmon, 8,5 cm FORCEPS, GENERAL & PLASTIC SURGERY Antihaft non stick Bipolar 11cm Maul 0,7mm, abgewinkelt Antihaft Bajonett Bipolar 25cm breiter Griff, Maul 2,0mm, abwarts gew. Antihaft Bajonett Bipolar 16cm Maul 2,0mm, gerade Antihaft non stick Bipolar 19,5cm Maul 1,0mm, abgewinkelt Bipolar 11cm, Maul 1,0mm, gerade ohne Stift 13/0720 Chirurgische Pinzette, 20 cm 10 0016 DeBakey GefaBpinzette atraumatisch 12/0414 anatomische Pinzette, fein, 14,5 cm Antihaft Bajonett Bipolar 19,5cm Maul 1,0mm, aufwarts gewinkelt 12/0412 anatomische Pinzette, fein, 11,5 cm 13/0620 Chirurgische Pinzette, 20 cm Antihaft non stick Bipolar 16cm Maul 2,0mm, gerade 13/2012 Chirurgische Pinzette, 12 cm 11/1015 Anat. Pinzette HM Semken, 15 cm 12/1815 anatomische Pinzette, 15 cm 13/0414 Chirurgische Pinzette, fein, 14,5 cm SCALER, PERIODONTIC TAP, BONE NEEDLE, ASPIRATION AND INJECTION, REUSABLE PICK, MICROSURGICAL EAR SCREWDRIVER CUTTER, WIRE OSTEOTOME SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING CURETTE, SURGICAL, GENERAL USE STETHOSCOPE, MANUAL DISH, TISSUE CULTURE GAUGE, DEPTH

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2025-01-27
FXE Speculum, Non-Illuminated General, Plastic Surgery Class 1 878.1800 2025-01-23
FNS Ring Cutter General Hospital Class 1 880.6200 2025-01-23
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2025-01-23
HXY Brace, Drill Orthopedic Class 1 888.4540 2025-01-28
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 2025-01-27
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 2025-01-23
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 2025-01-23
JEX Plier, Orthodontic Dental Class 1 872.4565 2025-01-23
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2025-01-23
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2025-01-23
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2025-01-27
GEF Applier, Staple, Surgical, General, Plastic Surgery Class 1 878.4800 2025-01-23
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2025-01-23
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2025-01-27
KQW Goniometer, Nonpowered Orthopedic Class 1 888.1520 2025-01-28
JYD Chisel, Mastoid General, Plastic Surgery Class 1 878.4800 2025-01-27
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2025-01-23
KBO Guillotine, Tonsil Ear, Nose, Throat Class 1 874.4420 2025-01-23
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2025-01-23
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2025-01-27
ILZ Accessories, Traction Physical Medicine Class 1 890.5925 2025-01-28
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2025-01-23
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2025-01-23
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2025-01-23
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-01-21
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-02-05
GWZ Percussor Neurology Class 1 882.1700 2025-01-23
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2025-01-23
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2025-01-27
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-01-23
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2025-01-23
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2025-01-27
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2025-01-23
JYK Holder, Ear Speculum General, Plastic Surgery Class 1 878.1800 2025-01-27
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-01-28
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2025-02-05
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2025-01-23
FNP Urinal General Hospital Class 1 880.6730 2025-01-23
FBW Filiform And Filiform Follower Gastroenterology, Urology Class 1 876.5520 2025-01-23
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-01-23
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2025-01-28
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2025-01-23
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2025-01-23
EMR File, Periodontic Dental Class 1 872.4565 2025-01-23
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2025-01-27
HWO Skid, Bone Orthopedic Class 1 888.4540 2025-01-28
EXX Probe, Rectal, Non-Powered Gastroenterology, Urology Class 1 876.4730 2025-01-23
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 2025-01-23
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2025-01-23
HPP Headlamp, Operating, Battery-Operated Ophthalmic Class 1 886.4335 2025-01-23
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 2025-01-23
HGE Amniotome Obstetrics/Gynecology Class 1 884.4530 2025-01-27
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2025-01-28
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2025-01-27
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2025-01-23
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 2025-01-23
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-01-28
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2025-01-23
HXW Bender Orthopedic Class 1 888.4540 2025-01-28
LJW Tracheotome Ear, Nose, Throat Class 1 874.4420 2025-01-28
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 2025-01-27
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 2025-01-23
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2025-01-27
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2025-01-27
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2025-01-23
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2025-01-23
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2025-01-23
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2025-01-27
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2025-01-23
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2025-01-23
HTD Forceps General, Plastic Surgery Class 1 878.4800 2025-01-27
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2025-01-28
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2025-01-27
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2025-01-28
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2025-01-28
HTP File Orthopedic Class 1 888.4540 2025-01-28
EIX Probe, Periodontic Dental Class 1 872.4565 2025-01-23
HTO Reamer Orthopedic Class 1 888.4540 2025-01-27
EJY Pliers, Operative Dental Class 1 872.4565 2025-01-23
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2025-01-27
EKB Explorer, Operative Dental Class 1 872.4565 2025-01-23
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2025-01-23
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2025-01-23
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2025-01-23
EJZ Knife, Margin Finishing, Operative Dental Class 1 872.4565 2025-01-23
HTF Curette General, Plastic Surgery Class 1 878.4800 2025-01-27
KBP Hook, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 2025-01-27
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2025-01-27
EMI File, Bone, Surgical Dental Class 1 872.4565 2025-01-23
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2025-01-27
HXC Wrench Orthopedic Class 1 888.4540 2025-01-28
JZE Spoon, Ear Ear, Nose, Throat Class 1 874.4420 2025-01-27
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2025-01-27
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2025-01-27
HWK Trephine Orthopedic Class 1 888.4540 2025-02-05
JZA Rongeur, Mastoid Ear, Nose, Throat Class 1 874.4420 2025-01-27
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2025-01-27
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 2025-01-27
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2025-01-23
HER Pelvimeter, External Obstetrics/Gynecology Class 1 884.4520 2025-01-27
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-01-23
EMN Scaler, Periodontic Dental Class 1 872.4565 2025-01-23
HWX Tap, Bone Orthopedic Class 1 888.4540 2025-01-28
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2025-01-23
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2025-01-27
HXX Screwdriver Orthopedic Class 1 888.4540 2025-01-28
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2025-01-28
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2025-01-28
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2025-01-23
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-01-23
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2025-01-28
KIZ Dish, Tissue Culture Hematology Class 1 864.2240 2025-01-28
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-01-23

Official Correspondent

Dirk Berninger

US Agent Details

Antonio Alonso Business: Delter Group Email: tony@deltercorp.com Phone: (786) 4732442

Related Public Records

Same Entity

Med2B Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142953 Optomedical Technologies GmbH OCT-Camera 2015-03-04
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2018 Optovue, Inc. 2
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018 Optovue, Inc. 2
iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0012-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
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.

Similar Registrations

Registration Number Establishment Name Location
8010251 HBH MEDIZINTECHNIK GMBH TUTTLINGEN Baden-Wurttemberg, DE
3035678069 MATTES INSTRUMENTE GMBH Tuttlingen-Nendingen Baden-Wurttemberg, DE
8010704 NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH TUTTLINGEN Baden-Wurttemberg, DE
9612086 B. BRAUN MEDICAL INDUSTRIES SDN. BHD. PENANG Pulau Pinang, MY
3006389770 MEDITEC DEVICES VASAI(E), THANE, MAHARASHTRA, IN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035708926. Last updated year: 2026. Please use registration number 3035708926 when referencing this establishment in official correspondence.
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