A&M BIOMEDICAL INC.

FDA Device Registration & Listing · Laguna Hills, CA, US · Registration 2951215

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
2951215
FEI Number
1000221492
Entity Name
A&M BIOMEDICAL INC.
City/State/Country
Laguna Hills, CA, US
Establishment Address
23042 Alcalde Dr Ste A, Laguna Hills, CA 92653, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ambiomedical.com (Owner Number: 10042343)
Owner / Operator Contact Address
23042 alcalde drive, suite a, Laguna Hills, CA 92653, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

mild 2 Yoni.Fit Bladder Support SCOUT MD Surgical Guidance System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-25
DRC Trocar Cardiovascular Class 2 870.1390 2016-12-19
HRX Arthroscope Orthopedic Class 2 888.1100 2024-07-22
HAE Rongeur, Manual Neurology Class 2 882.4840 2024-07-22
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2025-01-07
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2025-01-07

Official Correspondent

Melissa Fontes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ambiomedical.com
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
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K933654 Johnson & Johnson Medical, Inc. BLADDER NECK SUPPORT PROTHESIS FITTING KIT 1995-05-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.

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3014615697 AMNOTEC INTERNATIONAL MEDICAL GMBH Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252 ZAPALIGN LLC Fort Lauderdale, FL, US
3020978007 DONGGUAN BAO KANG DIAN ZI KE JI LIMITED Dongguan City Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2951215. Last updated year: 2026. Please use registration number 2951215 when referencing this establishment in official correspondence.
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