Human Med AG

SCHWERIN Mecklenburg-Western Pomerania, DE

HUMAN MED AG appears in FDA device records in SCHWERIN Mecklenburg-Western Pomerania, DE. FDA records list 2 510(k) clearances between 2008-08-13 and 2010-06-29, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

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 Human Med AG between 2008 and 2010. The busiest year on record is 2008, with 1. The most recent is 2010, with 1.

Clearances by year, as a table

510(k) clearance decisions for Human Med AG, by decision year
Year	Clearances
2008	1
2010	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K101713	LIPCOLLECTOR II	MUU	Substantially Equivalent	2010-06-29
K082025	BODY-JET	QPB	Substantially Equivalent	2008-08-13

Registered establishments

FDA registered establishments for Human Med AG, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3003587189	3003587189	HUMAN MED AG	WILHELM-HENNEMANN-STR.9, SCHWERIN Mecklenburg-Western Pomerania 19061 DE	2026	BYY FQH GCD GEA LXG QKL QPB

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
Recall	Product	Reason	Classification	Initiated	Status
Z-1251-2025	human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.	The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.	Class II	2024-10-18	Open, 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.

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What MDM checks, and what it does not

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain