Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004608878

FEI Number

3004608878

Entity Name

INTEGRA LIFESCIENCES CORPORATION

City/State/Country

CINCINNATI, OH, US

Establishment Address

4900 CHARLEMAR DR.,, BUILDING A, CINCINNATI, OH 45227, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Integra LifeSciences Corporation (Owner Number: 9004007)

Owner / Operator Contact Address

1100 Campus Rd, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Integra Padgett Jarit MicroFrance Integra MicroFrance Integra MAYFIELD Skull Clamp MAYFIELD 2 Skull Clamp Jarit Supercut Roto-Lok Roto-Cam Jarit Jarit Padgett MicroFrance Miltex Integra Miltex Integra Jarit Jarit Padgett Integra MicroFrance Miltex Jarit Integra MicroFrance Jarit Padgett MicroFrance Miltex Ruggles-Redmond Integra Jarit Padgett Integra Jarit MicroFrance Ruggles-Redmond Padgett Miltex Jarit Padgett MicroFrance Ruggles-Redmond Integra Miltex MicroFrance Miltex Padgett Jarit Integra Integra Integra Jarit Ruggles-Redmond Jarit LumbarTrak Ruggles-Redmond Miltex MicroFrance Integra Miltex Mayfield MR/CT Skull Clamp Jarit Miltex Codman Instrument Tray Integra Integra Allograft Wedge Instrument Tray Assembly Carb-N-Sert Miltex Jarit Jarit Supercut Padgett CARB-EDGE CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA Integra Miltex MicroFrance Jarit Integra Padgett Jarit Jarit Supercut MicroFrance Miltex Carb-N-Sert CARB-EDGE 5-700;5-702;5801;5803;5804 Miltex MicroFrance Jarit Integra Integra Jarit Miltex Padgett MicroFrance MicroFrance Integra Miltex MicroFrance Integra Acclarent Relieva Vortex 2 Jarit Padgett Miltex Mayfield Adult Disposable Skull Pin MicroFrance Integra Integra Jarit Miltex MicroFrance MicroFrance Miltex Padgett Integra Integra Miltex Integra Jarit Integra Jarit Miltex MicroFrance Integra MicroFrance Mayfield MicroFrance Integra BUDDE Halo Retractor System Padgett Integra Ruggles-Redmond MicroFrance Jarit Miltex Padgett Jarit Integra Miltex MicroFrance Nashold Biopsy Needle - Single Use Nashold Biopsy Needle - Disposable RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE CRW Biopsy Plus XKnife 5 Jarit Ruggles-Redmond Padgett Miltex Integra MicroFrance Galea Elevator Arkis Galea Elevator MicroFrance Jarit Miltex Integra Miltex Jarit MicroFrance Integra Carb-N-Sert Ruggles-Redmond Jarit Supercut Mayfield 2000 Radiolucent Skull Cla Jarit Integra Miltex Padgett MicroFrance Jarit Integra MicroFrance Jarit Integra Integra Miltex Jarit Mayfield Infinity XR2 Skull Clamp MicroFrance Padgett Jarit Miltex Integra 33-34-SH;33-35;33-35-SH;33-36;33-36-SH;33-37;33-38 33-31;33-31A;33-31AA;33-31AA-P/25;33-31A-P/25;33-31B;33-31-P/25;33-32;33-32-P/25;33-33;33-33-SH;33-34;33-34-P/25 MicroFrance Integra Jarit MicroFrance Integra Jarit Padgett CARDIO-GRIP Miltex Ruggles-Redmond Integra Integra MicroFrance Jarit Miltex Integra Miltex MicroFrance Jarit Mayfield A-2000 Skull Clamp Miltex Integra Jarit Ceram-A-Grip Miltex Petit-Point MicroFrance Jarit Padgett CARB-BITE Integra Miltex MicroFrance Integra Jarit MicroFrance Padgett Integra Jarit MicroFrance Miltex Integra Jarit Miltex Integra MicroFrance MicroFrance Integra Padgett Miltex Jarit Ruggles-Redmond MicroFrance Integra MicroFrance Integra Padgett MicroFrance Miltex Integra Jarit Padgett Miltex Jarit 5-800 Miltex Integra Jarit MicroFrance Padgett Jarit Miltex Integra MAYFIELD CARB-BITE Jarit Ruggles-Redmond Integra Anti-Rotation Peg Holder Integra Allograft Wedge Sizer Instrument Integra Allograft Wedge Instrument Set Jarit MicroFrance Integra Miltex Padgett Gill-Thomas Cosman GTC Dental Tray MicroFrance Integra Integra MicroFrance Jarit MicroFrance Integra Miltex MicroFrance Padgett Jarit Ruggles-Redmond Miltex Integra Integra Jarit Padgett Ceram-A-Grip Jarit Grip Deep Miltex Xcision Petit-Point Jarit Integra GENERAL INSTRUMENT Padgett Integra MicroFrance Jarit Integra MicroFrance Jarit Miltex Integra Jarit Integra Miltex Miltex Integra MicroFrance Jarit Integra Jarit MicroFrance Miltex Cardio-Grip Miltex Jarit Padgett Miltex MicroFrance Jarit Integra Ruggles-Redmond MicroFrance Integra MicroFrance Jarit Redmond Integra Integra Jarit Miltex Jarit Integra Miltex Integra Luxtec UltraLitePro UltraLite Plus MicroFrance Padgett Miltex Integra Jarit Padgett MicroFrance Integra Jarit Padgett Miltex Integra Jarit Mayfield Child Disposable Skull Pin Integra MicroFrance Integra Jarit Miltex MicroFrance MicroFrance Miltex Integra 33-100;4-410;4-411;4-412;4-415;4-420;4-421;4-422;4-423;4-510;4-511;4-512;4-515;4-515C;4-522 Jarit Padgett Miltex MicroFrance Integra Jarit Miltex Jarit Integra Integra Jarit Miltex Ruggles-Redmond Miltex Jarit Jarit Integra MicroFrance Miltex MicroFrance Integra MicroFrance Jarit Integra Integra Jarit Miltex Jarit Integra Integra Miltex Integra Jarit Probe 8" MicroFrance Integra Integra Miltex MicroFrance Mayfield Titanium Skull Pins Reusab Mayfield Titanium Skull Pins Dispos Padgett Jarit MicroFrance CARB-BITE Miltex Integra Miltex Jarit Padgett Petit-Point MicroFrance Integra MicroFrance Integra Integra Ruggles-Redmond MicroFrance Integra MicroFrance Integra Miltex Jarit Padgett Integra Blade P4596 Miltex Jarit CRW-1 System CRW Precision Arc Steriotactic System CRW Padgett Integra Miltex MicroFrance Jarit Jarit Miltex Integra Integra MicroFrance Carb-N-Sert Miltex Integra MicroFrance Jarit Ruggles-Redmond Padgett Diamond Integra Padgett Padgett Integra Miltex Miltex Cryosolutions MicroFrance Integra Jarit Miltex Integra Padgett Miltex Integra Jarit MicroFrance 33-52;33-53;33-54;33-55;33-57 Integra MicroFrance MicroFrance Integra Cosgrove Depth Electrode Kit MicroFrance Jarit Miltex Integra Thompson MicroFrance Padgett Jarit Miltex Integra MicroFrance Integra MicroFrance Integra Jarit Miltex Integra MicroFrance Integra MicroFrance Jarit Integra Integra Jarit Miltex MicroFrance Relieva Sidekick LP Acclarent Relieva Flex Guide Catheter Integra Jarit Ruggles-Redmond Codman Ventricular Needles Subcutaneous Guidewire Arkis Subcutaneous Guideware Miltex Jarit Padgett Integra MicroFrance Padgett Jarit Integra Miltex Integra Miltex MicroFrance Jarit Miltex Mayfield Infinity Skull Clamp MicroFrance Integra Mayfield Base Unit Padgett Miltex MicroFrance Jarit Integra Jarit Miltex MicroFrance Integra Jarit Miltex MicroFrance Integra Integra Miltex MicroFrance Integra Jarit Integra Padgett Jarit Miltex MicroFrance Jarit Integra Jarit Ruggles-Redmond Padgett Integra Miltex MicroFrance Mayfield MR/X-Ray Skull Clamp Miltex Jarit Integra MicroFrance Padgett Ruggles-Redmond Mayfield Adult Disposable Skull Pin Jarit Miltex MicroFrance Integra Jarit Miltex Integra Padgett Jarit Ruggles-Redmond CODMAN Bipolar Cords

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-09-25
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2004-11-09
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-03-28
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2015-03-31
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2009-11-20
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1981-04-24
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2014-01-13
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2004-11-09
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-04-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-07-16
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1981-04-24
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-09-25
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	1998-08-24
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2009-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-11-04
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2011-05-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-03-25
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2000-12-14
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-09-09
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2016-10-21
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-10-21
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	1999-05-19
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-09-09
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1981-04-24
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2000-10-17
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2014-11-05
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2003-08-05
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2015-03-28
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2003-09-04
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2001-08-06
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
JYK	Holder, Ear Speculum	General, Plastic Surgery	Class 1	878.1800	1999-06-01
HBM	Headrest, Neurosurgical	Neurology	Class 1	882.4440	2004-07-20
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	1998-12-31
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2008-01-04
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2007-06-27
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2007-12-12
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2011-02-24
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1981-04-24
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1981-04-24
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1981-04-24
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2003-08-05
MZY	Graft, Vascular, Stainless Steel Tunneler	Cardiovascular	Class 2	870.3450	2013-03-18
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-08-07
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2009-12-14
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-08-05
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2009-11-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2014-11-04
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2012-07-18
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2000-10-17
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-02-05
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2003-09-09
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2007-01-18
NNR	Block, Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2004-10-05
KAQ	Gouge, Nasal, Ent	Ear, Nose, Throat	Class 1	874.4420	2007-06-27
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2003-07-07
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2015-01-19
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2003-09-04
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2001-08-09
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2016-02-23
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2005-03-24
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1981-04-24
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2007-12-12
JZY	Knife, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
JYY	Rasp, Ear	Ear, Nose, Throat	Class 1	874.4420	2009-11-19
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
HTX	Rongeur	Orthopedic	Class 1	888.4540	1981-04-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-06-04
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	1981-04-24
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-09-09
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2003-07-07
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2009-11-19
HDM	Packer, Uterine	Obstetrics/Gynecology	Class 1	884.4520	1981-04-24
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1981-04-24
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2014-04-15
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2000-12-14
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2015-03-28
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2009-11-13
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2018-11-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-11-01
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2007-12-04
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-06-04
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2007-05-29
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2015-02-06
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
KBQ	Knife, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-08-05
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1981-04-24
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2012-07-09
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2015-05-07
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2008-02-25
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2004-06-04
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
JYF	Clamp, Ossicle Holding	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-06-04
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2003-09-04
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	1999-02-12
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2007-12-07
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2003-09-09
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2014-09-03
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2001-04-26
KAJ	Mobilizer, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
KBH	Adenotome	Ear, Nose, Throat	Class 1	874.4420	1981-02-24
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2007-06-27
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2008-02-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-12-21
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-02-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-02-25
JYZ	Rod, Measuring Ear	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2005-01-18
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2010-05-26
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
EYR	Tourniquet, Gastro-Urology	General, Plastic Surgery	Class 1	878.5900	2004-06-04
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2003-08-05
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2004-11-09
NNP	Die, Wire Bending, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2015-03-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2011-11-23
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2008-03-25
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1999-06-09
JYP	Knife, Myringotomy	Ear, Nose, Throat	Class 1	874.4420	2009-11-19
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
JYW	Press, Vein	Ear, Nose, Throat	Class 1	874.4420	2004-06-07
FXG	Specula Accessories	General, Plastic Surgery	Class 1	878.1800	2014-11-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-06-04
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1999-04-27
KTZ	Caliper	Orthopedic	Class 1	888.4150	1999-05-10
HWQ	Passer	Orthopedic	Class 1	888.4540	2007-06-27
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2006-03-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-02-10
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	1981-04-24
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2015-03-30
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-04-24
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	1981-04-24
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2015-03-30
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1981-04-24
JYM	Inserter, Myringotomy Tube	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2015-08-25
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
JZA	Rongeur, Mastoid	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	1981-04-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-06-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integra LifeSciences 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
3015194982	SURGICAL INNOVATION ASSOCIATES, INC.	Chicago, IL, US
3013505638	REBOUND THERAPEUTICS, CORPORATION	Irvine, CA, US
3006697299	INTEGRA LIFESCIENCES (IRELAND) LIMITED	SRAGH TULLAMORE Offaly, IE
2648988	INTEGRA NEUROSCIENCES	ANASCO, PR, US
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

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K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA

Similar Registrations

Registration Number	Establishment Name	Location
3021119558	Assembly-Tek LLC	Dayton, OH, US
3014191428	TydenBrooks	Tallapoosa, GA, US
3008132392	Medicom Asia-Pacific Holdings Limited. Taiwan Branch	Wujie Township Yilan, TW
1526531	STERIS Corporation	CLEVELAND, OH, US
3005706667	TURNER MEDICAL INC.	Athens, AL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004608878. Last updated year: 2026. Please use registration number 3004608878 when referencing this establishment in official correspondence.