510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bosch Healthcare Solutions GmbH

Waiblingen Baden-Wurttemberg, DE

BOSCH HEALTHCARE SOLUTIONS GMBH appears in FDA device records in Waiblingen Baden-Wurttemberg, DE. FDA records list 2 510(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
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Bosch Healthcare Solutions GmbH between 2024 and 2025. The busiest year on record is 2024, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bosch Healthcare Solutions GmbH, by decision year
YearClearances
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243926Vivatmo pro-SMXASubstantially Equivalent
K233775Vivatmo proMXASubstantially Equivalent

Registered establishments

FDA registered establishments for Bosch Healthcare Solutions GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30010823933001082393BOSCH HEALTHCARE SOLUTIONS GMBHAlte Bundesstrasse 50, Waiblingen Baden-Wurttemberg 71332 DE2026

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.

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