FDA Registration
Active
🇲🇽 Mexico
ETHICON, INC.
Reg #: 3006638824
·
FEI: 3006638824
·
Expires 2026
Products
36
Proprietary Names
161
Establishment Types
2
Classifications
36
Registration Details
- Registration Name
- ETHICON, INC.
- Registration Number
- 3006638824
- FEI Number
- 3006638824
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Calle Durango No. 2751, LOTE BRAVO
- City
- CIUDAD JUAREZ Chihuahua
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K811872
- PMA Number
- N18331
Owner / Operator
- Firm Name
- ETHICON INC.
- Operator Number
- 2210968
- Address
- 1000 US Highway 202 S.
- City
- Raritan
- State
- NJ
- Postal Code
- 08869
- Country
- US
- Correspondent
- Reynaldo Librojo
US Agent
- Business Name
- ETHICON Inc
- Contact Name
- Reynaldo Librojo
- Address
- 1000 Us Highway 202
- City
- Raritan
- State
- NJ
- ZIP
- 08869
- Country
- US
- [email protected]
- Phone
- 908 8086028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2012-02-08 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-11-23 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2023-08-24 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-01-16 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2026-02-19 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2026-02-19 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2018-12-12 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2019-01-14 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2014-04-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-08-24 |
| Needle, Cerclage, Gynecological | HDH | Class 1 | Obstetrics/Gynecology | No | 2016-07-21 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2013-12-11 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-08-23 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 1991-12-20 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-08-23 |
| Suture, Absorbable, Synthetic | GAN | Class 2 | General, Plastic Surgery | No | 2008-03-20 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2023-08-24 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2023-11-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-04-10 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 1992-10-15 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1993-11-16 |
| Electrocautery, Gynecologic (And Accessories) | HGI | Class 2 | Obstetrics/Gynecology | No | 2021-11-10 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 1977-12-20 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2017-11-03 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2019-03-18 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2018-08-16 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2021-11-10 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2013-02-13 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2008-03-26 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2008-03-26 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2023-08-23 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-06-12 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1992-10-15 |
| Applier, Staple, Surgical, | GEF | Class 1 | General, Plastic Surgery | No | 2023-08-23 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2012-08-17 |
| Implant, Anti-Gastroesophageal Reflux | LEI | Class 3 | Unknown | No | 2025-11-24 |
Proprietary Names
PROLENE on TEFLON Pledget Suture Buttress
E-Z Clean electrosurgical electrodes
DePuy Mitek - GRYPHON BR
GRYPHON PEEK
Mitek TIGHT-N Anchor
Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor,
Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device
Cotton Umbilical Tape
Electrosurgical Electrode
DePuy Mitek - GRYPHON
GRYPHON® P PEEK Anchor with DYNACORD
GRYPHON® P BR DS Anchor with DYNACORD
DePuy Mitek - GRYPHON® P BR Anchor with DYNACORD
GRYPHON® P PEEK DS Anchor with DYNACORD
PDS II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
VICRYL (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture
DePuy Mitek - Latarjet
MERSILENE WHITE WOVEN Polyester Fiber Ligature
MERSILENE Tape
MERSILENE WHITE WOVEN Polyester Fiber Strip
DePuy Mitek - HEALIX BR
PROLENE Polypropylene Nonabsorbable Suture
DePuy Mitek - GRYPHON Flex Knotless PEEK and Biocomposite Anchors
E-Z Clean Laparoscopic Electrode
DePuy Mitek Instrument
DePuy Mitek - ACORN Reamer Sterile (various sizes)
Mersilene Tape
Nylon Tape
DePuy Mitek - IDEAL SUTGRASPER (various sizes)
DePuy Mitek - Arthroscopic Instruments
MONOCRYL (Dyed) Suture
DePuy Mitek - FASTIN RC
Modified Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture
DePuy Mitek - Versalok Pre-packed W/Orthocord
Depuy Mitek - VERSALOK
DePuy Mitek - ORTHOCORD
NEUWAVE Microwave Ablation System and Accessories
MONOCRYL PLUS Antibacterial (Poliglecaprone 25) Suture
Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture
HIP STRAIGHT BLADE
HIP CURVED BLADE, HIP ACCESS KIT CURVE BLADE, HIP ACCESS KIT NO BLADE
HEALIX ADV 4.5 HARD BONE INST
GUIDEWIRE 12 INCH STERILE 6PK
1.1 MM TROCAR TIP GUIDEWIRE
1.6MM GUIDEWIREETO
ACL ACC DISPOSABLES KIT *EA
ADJ. DISPOSABLESYSTEM
CHIA PERCPASSER SUTURE PASSER 5 PACK
GUIDEWIRE 12 INCH STERILE 1EA
HIP ACCESS KIT STR BLADE
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
PDS II Suture
DePuy Synthes - OUTSIDE-IN DISPOSABLE KIT
DePuy Synthes - RIGIDLOOP DISPOSABLES SYSTM
DePuy Mitek - Milagro Interference Screws
DePuy Mitek - Milagro Advance Interference Screws
DePuy Mitek - Super Anchor - Orthocord
DePuy Mitek - HEALIX ADVANCE
DePuy Mitek - PROFILE
DePuy Mitek - MILAGRO ADVANCE
MITEK DRILL GUIDE
DePuy Mitek - ABSOLUTE G-W NTNL 1.1MMX15" *PK/6
DePuy Mitek - MILAGRO BR
DePuy Mitek - Truespan
DePuy Mitek - DYNATAPE Suture
PDS Plus Antibacterial Suture
Lletz Loop Electrodes
DePuy Synthes - Free Needle Loop OS-6 12PK
DePuy Synthes - Free Needle Loop OS-6 1EA
Surgical Stainless Steel Suture
MegaTip
ETHILON Blue Suture
DYNACORD Sutures (Blue, White/Blue/Green), with OS-6 needles. Multi (12) Pack
DYNACORD Suture (White/Blue/Green), no needles. Single Pack
DYNACORD Suture (White/Blue/Green), no needles. Multi (12) Pack
DYNACORD Suture (Blue), with MO-7 needle. Multi (12) Pack
DYNACORD Sutures (Blue, White/Blue/Green), with MO-7 needles. Single Pack
DYNACORD Suture (Blue), no needles. Multi (12) Pack
DYNACORD Sutures (Blue, White/Blue/Green), with OS-6 needles. Single Pack
DYNACORD Suture (Blue), with OS-6 needle. Single Pack
DYNACORD Sutures (Blue, White/Blue/Green), no needles. Single Pack
DYNACORD Sutures (Blue, White/Blue/Green), with MO-7 needles. Multi (12) Pack
DePuy Mitek - DYNACORD Suture (Blue), no needles. Single Pack
DYNACORD Sutures (Blue, White/Blue/Green), no needles. Multi (12) Pack
DYNACORD Suture (Blue), with OS-6 needle. Multi (12) Pack
DYNACORD Suture (Blue), with MO-7 needle. Single Pack
TFE Polymer Pledgets
DePuy Mitek - HEALIX ADVANCE with DYNATAPE
DePuy Mitek - RIGIDLOOP ADJUSTABLE
DePuy Mitek - HEALIX ADVANCE KNOTLESS
DePuy Mitek - HEALIX Ti
Temporary Cardiac Pacing Wire
Megadyne Laparoscopic Tubing
Megadyne Speculum Tubing
DePuy Mitek - GRYPHON PEEK
DePuy Mitek - SPEEDTRAP
DePuy Mitek - RIGIDFIX
SECURESTRAP Open Absorbable Strap Fixation Device
DePuy Mitek - MINILOK
DePuy Mitek - QUICKANCHOR
DePuy Mitek - OMNISPAN
DePuy Mitek - PERMALOOP Suture, PERMATAPE Suture
DePuy Mitek - Healix Ti with DYNATAPE
DePuy Mitek - Intrafix Advance
PRONOVA Poly (Hexafluoropropylene - VDF) Suture
DePuy Mitek - RigidFix PLA
DePuy Mitek - GII
MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
DePuy Mitek - BIOKNOTLESS
DePuy Mitek - INTRAFIX
DePuy Mitek - LUPINE
PDS Plus (Polydioxanone) Antibacterial Suture
MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
DePuy Mitek - Healix Advance
DePuy Mitek - HEALIX ADVANCE BR WITH PERMACORD
HEALIX ADVANCE PEEK ANCHORS WITH PERMACORD
DePuy Mitek - HEALIX PEEK
DePuy Mitek - Healix Advance Knotless, Healix Advance Self-Punching
DePuy Mitek - Healix Advance SP
MILAGRO ADVANCE
DePuy Mitek - RIGIDLOOP
MICROFIX QUICKANCHOR
MICROFIX
DePuy Mitek - HEALIX TRANSTEND PEEK
HEALIX TRANSTEND
HEALIX PEEK
HEALIX BR
DePuy Mitek - PERMATAPE
DePuy Mitek - HEALIX ADVANCE PEEK
COATED VICRYL SUTURE
PERMA-HAND/Mersilk Suture/Silk Suture
ETHILON Nylon Suture
NUROLON
ETHIBOND
ETHIBOND EXCEL
SURGICAL GUT SUTURE (Plain and Chromic)
MERSILENE, MERSUTURE
DePuy Mitek - ACL GRAFT KNIVES
DePuy Mitek - COMBO BEATHPIN
DePuy Mitek - 4.5 LONGER TIP BEATH PIN
DePuy Mitek - MULTIPLE CANNULAE
DePuy Mitek - RESTORE TIB CANN THRD *PK/5
GRYPHON X Anchor
HEALIX TRANSTEND Anchor
DePuy Mitek - INSERTER
DePuy Mitek - BIOINTRAFIX
ETHICON SECURESTRAP Absorbable Strap Fixation Device
DePuy Mitek - RIGIDFIX CURVE
All-In-One
DePuy Mitek - HEALIX
DePuy Mitek - Healix Ti with Dynacord
MONOCRYL Plus Antibacterial Suture
ETHICON ENDOSUTURE System
TORAX - LINX Reflux Management System
DePuy Mitek - HEALIX ADVANCE Anchors with DYNACORD Suture
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)