Data / Medical devices / Germany / Human Med AG

Human Med AG: FDA-registered device maker in SCHWERIN Mecklenburg-Western Pomerania, Germany, 2 510(k) clearances

Name: Human Med AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Human Med AG is registered with the FDA (registration 3003587189) in SCHWERIN Mecklenburg-Western Pomerania, Germany. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 13, 2008. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003587189
Address: Wilhelm-Hennemann-Str.9, SCHWERIN Mecklenburg-Western Pomerania, Germany, 19061
Owner or operator: Human Med AG (9043320)
Roles: Manufacturer
First device listed: September 12, 2008
Registered through: 2026
Brand names listed: Biofill Infiltration cannula (Model #: 580107), Biofill Infiltration cannula, 2.5mm D, 15cm L, single-use (Model #: 1580107), Biofill applicator, for Biofill cannulas (for body-jet evo and body-jet eco only) (Model #: 580001), Biofill cannula (Model #: 580086), Biofill cannula (Model #: 580089), Biofill cannula, 2 long suction holes, 3.5mm D, 15cm L, single-use (Model #: 1580086), Biofill cannula, 3.8mm D, 15cm L, 4 suction holes (Model #: 580125), Biofill cannula, 3.8mm D, 15cm L, 4 suction holes, RAPID (Model #: 581125) and more

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Connector, Catheter	GCD	1	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer	accessdata.fda.gov
Lipoaspirate Washing System For Aesthetic Body Contouring	QKL	2	Manufacturer	accessdata.fda.gov
System, Suction, Lipoplasty For Removal	QPB	2	Manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 13, 2008	K082025	BODY-JET	QPB	Substantially Equivalent	Human Med AG	accessdata.fda.gov
October 10, 2001	K012464	HELIX HYDRO-JET	FQH	Substantially Equivalent	Andreas Pein Medizintechnik GmbH	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 18, 2024	96137	Class II	Ongoing	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.	accessdata.fda.gov

Compare with other makers

Updated February 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.