Sklar Corporation - Warehouse

FDA Device Registration & Listing · Salisbury, MD, US · Registration 3015895045

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
3015895045
FEI Number
3015895045
Entity Name
Sklar Corporation - Warehouse
City/State/Country
Salisbury, MD, US
Establishment Address
2015 Industrial Parkway, Salisbury, MD 21801, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Sklar Corporation (Owner Number: 10023634)
Owner / Operator Contact Address
1333 Lenape Rd., West Chester, PA 19382, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sklar Instruments Sound Sccissors, Strabismus 4" Curved Twister curette curette Explorer Cutter OBSTETRICAL FORCEPS Wrap Dilator brushes Pick Corneal Trephine Elevator Kirschner Wire/Steinmann Pin Sklar Instruments Laryngoscope Bowl Headband Cannula Excavator Retractor Mallet Band Setter Needle Dilator Bougie Plier Gauge Specula Hook Arthroscopic Accessories Probe Amputation Knife Nasal Knife Curette Trocar cutter File Forceps Rasp Sterile Indicator Tray Otoscope Elevator Cast Spreader Sklar Instruments Hook Gag Impression Tray Scissors, Iris Sklar Instruments Tip Protector Suction Tube Spatula Filling Instrument Adenoid Curette Spatula Thorek Scissors 7.25 & 10" Gouge Biopsy Forceps Scrub Brush Knife Sklar Trays Sklar Instruments Urethrotome Clip Hook Hook Sklar Sklar Cannula, Perfusion, Fallo Chisel Osteotome Applier Tonometer Rudd-Clinic Hermorrhoidal Forceps Saw Medicine Cup Sklar Instruments Rasp Wire Cutting Plier Extractor Scaler pessary Kevorkian-Young Biopsy Curette ENT Punch Eyeshield Cannula, Perfusion, Fallopian Tube Probe Scissors Biopsy Punch Spatula Saw Cardiovascular Hemorrhoidal Ligator Clamp Crown Remover Scissor Gauze and Ligature Director Sklar Sterile General Purpose Tray Elevator Ear Knife, Politzer Cuff Sterile Bowl Recloseable Bag Curette Dental Bur Brushes mallet File Sklar General Surgical Gown Saw Vaginal Speculum nonmetel Probe Mouth Mirror Scissor ENT Syringe Sklar punch Dermatoscope Cutter, Surgical Penis Clamp Marcuse Tube Clamping Forceps Str Pencils Scoop Marker needle Suction Tube Clip Trays Ligator Elevator Caliper Hammer Awl Blade Trach Tube Dilator Forceps Curette trach tube Chisel Scissor Urology Guide Plier Probe and Director I.D. Roll Tape Gusberg Hysterectomy clamp Dilator Tamp Laparoscopic Dissector Blade File Sklar Instruments Sklar Amniocentesis Tray Trocar

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2008-12-17
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 2018-03-16
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2007-12-06
HXS Twister, Wire Orthopedic Class 1 888.4540 2017-10-11
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2013-05-10
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-05-10
EKB Explorer, Operative Dental Class 1 872.4565 2018-03-15
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2018-12-11
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2016-08-09
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2016-08-09
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2018-11-13
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2016-06-29
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2018-11-13
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2024-07-25
HTE Elevator General, Plastic Surgery Class 1 878.4800 2024-01-11
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2017-12-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-20
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2013-05-10
HTD Forceps General, Plastic Surgery Class 1 878.4800 2008-12-17
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2018-11-13
FNY Basin, Emesis General Hospital Class 1 880.6730 2024-07-03
HKF Mirror, Headband, Ophthalmic Ophthalmic Class 1 886.1500 2018-07-19
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-19
EKC Excavator, Dental, Operative Dental Class 1 872.4565 2023-12-13
EIG Retractor, All Types Dental Class 1 872.4565 2022-12-29
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-03-19
ECR Setter, Band, Orthodontic Dental Class 1 872.4565 2024-01-03
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2017-10-17
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2017-10-17
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 2019-11-19
EJY Pliers, Operative Dental Class 1 872.4565 2018-12-11
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2018-12-11
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2018-11-13
KBP Hook, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 2018-03-23
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2023-12-11
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2018-11-13
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2018-11-13
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2018-11-13
EKE Curette, Operative Dental Class 1 872.4565 2018-11-13
DRC Trocar Cardiovascular Class 2 870.1390 2019-07-15
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2013-05-10
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-07-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-10-12
HTR Rasp General, Plastic Surgery Class 1 878.4800 2017-10-11
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2017-06-19
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-07-20
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2018-07-20
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2018-03-16
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2018-03-19
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2008-12-17
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2018-12-11
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2018-03-15
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2018-11-13
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2007-12-06
LXZ Guard, Instrument General, Plastic Surgery Class 1 878.4800 2022-03-16
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2024-01-11
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2017-06-19
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 2018-03-19
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2018-11-13
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-11-13
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2007-12-06
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-03-19
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2024-08-16
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2016-06-29
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2018-12-11
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2015-04-01
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-08-09
FTN Plastic Surgery And Accessories Kit General, Plastic Surgery Class 1 878.3925 2008-12-17
EZO Urethrotome Gastroenterology, Urology Class 2 876.4770 2021-02-03
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2018-12-11
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2018-12-11
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2018-12-11
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2015-04-01
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2015-05-13
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-12-06
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2018-03-23
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2018-11-13
HKY Tonometer, Manual Ophthalmic Class 2 886.1930 2017-12-20
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2007-12-06
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 2018-11-13
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2024-07-03
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2008-12-17
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-11-13
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2022-12-29
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2018-11-13
EMN Scaler, Periodontic Dental Class 1 872.4565 2018-03-19
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2016-10-12
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2007-12-06
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2024-02-02
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2019-05-14
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2007-12-06
EIX Probe, Periodontic Dental Class 1 872.4565 2019-05-14
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 2022-08-16
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2007-12-06
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-19
HSO Saw General, Plastic Surgery Class 1 878.4800 2024-01-11
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2018-11-13
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2007-12-06
HFX Clamp, Circumcision Obstetrics/Gynecology Class 2 884.4530 2016-08-09
EIS Remover, Crown Dental Class 1 872.4565 2024-01-11
JYA Scissors, Wire Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2018-03-23
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2022-12-29
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2008-02-04
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-03-16
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2007-12-05
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2017-02-10
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2024-07-03
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-16
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2022-12-29
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2016-06-29
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-05-10
EMI File, Bone, Surgical Dental Class 1 872.4565 2018-03-15
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2009-11-10
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2021-03-22
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2016-08-09
HXB Probe Orthopedic Class 1 888.4540 2017-10-11
EAX Mirror, Mouth Dental Class 1 872.4565 2018-07-20
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2018-03-19
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2024-01-11
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2015-04-01
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2013-05-10
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 2020-09-09
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2007-12-06
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2023-12-13
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-12-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-10
FHL Scoop Gastroenterology, Urology Class 1 876.4730 2018-12-11
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2017-02-23
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2013-05-10
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2022-02-03
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2017-02-10
MCH Clip, Hemostatic General, Plastic Surgery Class 2 878.4300 2017-02-10
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-08-09
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2019-07-15
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2018-03-19
KTZ Caliper Orthopedic Class 1 888.4150 2024-01-11
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2018-03-23
HWJ Awl Orthopedic Class 1 888.4540 2018-03-23
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2018-03-15
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2017-09-05
HDX Dilator, Vaginal Obstetrics/Gynecology Class 2 884.3900 2017-02-10
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2018-03-16
HTF Curette General, Plastic Surgery Class 1 878.4800 2018-11-13
EPE Brush, Cleaning, Tracheal Tube Anesthesiology Class 1 868.5795 2016-06-29
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2019-05-14
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2018-03-19
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2017-02-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-10
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2017-02-10
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2017-02-10
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2017-02-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-02-10
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-02-10
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2017-02-10
FGC Urethroscope Gastroenterology, Urology Class 2 876.1500 2017-02-10
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2017-02-10
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2017-02-10
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2017-02-10
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2017-02-10
EZO Urethrotome Gastroenterology, Urology Class 2 876.4770 2017-02-10
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2017-02-10
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-02-10
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-02-10
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2017-02-10
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2017-02-10
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2017-02-10
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2017-02-10
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2017-02-10
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2017-02-10
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-05-14
FJY Plier, Crimp Gastroenterology, Urology Class 1 876.5540 2018-12-11
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2018-03-23
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2022-03-16
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-12-06
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2018-03-23
HXG Tamp Orthopedic Class 1 888.4540 2018-11-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-02-28
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2018-07-19
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2018-11-13
EMR File, Periodontic Dental Class 1 872.4565 2019-05-14
FQM Bandage, Elastic General Hospital Class 1 880.5075 2008-12-17
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2008-02-05
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2018-03-19

Official Correspondent

Debasish Ghosh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
2431166 Sklar Corporation West Chester, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223112 Smith & Nephew, Inc. MAVERICK Mini External Fixation System 2022-12-08
K895079 Buckman Co., Inc. ACE BEADED K-WIRES ACE OLIVE WIRES 1989-09-13
K922193 Osteo AG OSTEO KIRSCHNER WIRE 1992-07-23
K850026 Kirkstil Corp., Inc. ORTHOPEDIC IMPLANT NAILS & PINS 1985-05-20
K963367 Rms Div. RMS K-WIRE 1996-10-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2012 X Spine Systems Inc 1
Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

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