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

Carl Zeiss Suzhou Co., Ltd.

Suzhou Jiangsu, CN

Carl Zeiss Suzhou Co., Ltd. appears in FDA device records in Suzhou Jiangsu, CN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Carl Zeiss Suzhou Co., Ltd. between 2017 and 2018. The busiest year on record is 2017, with 1. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Carl Zeiss Suzhou Co., Ltd., by decision year
YearClearances
20171
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K171007Fluorescence ModeNBLSubstantially Equivalent
K163195PRIMUSOBOSubstantially Equivalent

Registered establishments

FDA registered establishments for Carl Zeiss Suzhou Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30085648983008564898Carl Zeiss Suzhou Co., Ltd.No.26 Wusheng Road, Suzhou Jiangsu 215126 CN2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0183-2024OPMI LUMERA 300, REF 6137Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.Class IIOpen, Classified

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 Carl Zeiss Suzhou 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