Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2531321

FEI Number

3001237758

Entity Name

Roechling Medical Lancaster, LLC

City/State/Country

DENVER, PA, US

Establishment Address

44 DENVER RD., DENVER, PA 17517, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Roechling Medical Rochester, L.P. (Owner Number: 10048821)

Owner / Operator Contact Address

999 Ridgeway Ave, Rochester, NY 14615, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FILLER, BONE VOID, CALCIUM COMPOUND BioSphere Putty Bioactive Bone Graft SYSTEM, DELIVERY, ALLERGEN AND VACCINE ARTHROSCOPE SYSTEM, DELIVERY, ALLERGEN AND VACCINE CANNULA, TROCAR, OPHTHALMIC BioSphere MIS Putty CATHETER, CONTINUOUS FLUSH Platelet And Plasma Separator For Bone Graft Handling ARTHROSCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-07-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-11-28
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2018-07-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-07-10
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2018-07-10
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-07-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-11-28
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2018-07-10
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2018-07-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Roechling Medical Rochester, L.P.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001397320	ROECHLING MEDICAL ROCHESTER L.P.	Rochester, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K000299	Biomedex, Inc.	DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D	2000-04-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2531321. Last updated year: 2026. Please use registration number 2531321 when referencing this establishment in official correspondence.