510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Baui Biotech Co., Ltd.

New Taipei City, TW

BAUI BIOTECH CO., LTD. appears in FDA device records in New Taipei City, TW. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Baui Biotech Co., Ltd. between 2017 and 2024. The busiest year on record is 2019, with 2. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Baui Biotech Co., Ltd., by decision year
YearClearances
20171
20192
20201
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242899NOVA Minimally Invasive SystemNKBSubstantially Equivalent
K191353COMET Lumbar Interbody Fusion CageMAXSubstantially Equivalent
K191494Facilis™ Spinal SystemNKBSubstantially Equivalent
K182416NOVA Minimally Invasive SystemNKBSubstantially Equivalent
K161231Facilis™ Spinal SystemNKBSubstantially Equivalent

Registered establishments

FDA registered establishments for Baui Biotech Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30135146483013514648BAUI BIOTECH CO., LTD.6F., No.8, Sec.1, Zhongxing Rd., New Taipei City 24872 TW2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Baui Biotech Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain