Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021680161

FEI Number

3021680161

Entity Name

BEAR-ENT, LLC

City/State/Country

Malvern, PA, US

Establishment Address

274 Lancaster Ave., Suite 208, Malvern, PA 19355, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

BEAR-ENT, LLC (Owner Number: 10084364)

Owner / Operator Contact Address

274 Lancaster Ave., Suite 208, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR GEIZ BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR BEAR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
JYK	Holder, Ear Speculum	General, Plastic Surgery	Class 1	878.1800	2022-05-03
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2023-07-24
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2025-03-10
JYW	Press, Vein	Ear, Nose, Throat	Class 1	874.4420	2026-05-19
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2022-09-01
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2022-02-26
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-07-18
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2023-03-09
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2022-08-02
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2022-02-26
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-02-16
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2024-03-20
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-02-26
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
NNQ	Forceps, Wire Closure, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2022-02-26
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2022-02-14
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-04-20
JZD	Snare, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-08-01
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-03-31
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2022-02-26
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2022-02-23
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2022-02-27
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2022-04-21
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2022-02-26
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-09-13
KAJ	Mobilizer, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-04-23
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2022-08-17
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2022-08-17
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2022-02-26
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2022-02-26
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-02-26
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-02-26
JYZ	Rod, Measuring Ear	Ear, Nose, Throat	Class 1	874.4420	2023-07-26
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2022-08-02
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2022-02-26
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2022-02-26

Official Correspondent

David Burke

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BEAR-ENT, LLC

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
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
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-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021680161. Last updated year: 2026. Please use registration number 3021680161 when referencing this establishment in official correspondence.