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AMERICAN MEDICAL SYSTEMS, INC.

United States·US-MF-000002745

Last updated May 23, 2026

What AMERICAN MEDICAL SYSTEMS, INC. makes

American Medical Systems, Inc. manufactures surgical laser systems, including frequency-doubled solid-state lasers like the GreenLight XPS and HPS for urogenital procedures, as well as accessories such as single-use beam guides, foot-switches, and operator eye protection filters. The company also produces rigid penile prostheses, including models like SureFlex and SureFlex 200, alongside video camera inserts for surgical visualization. Electrical mains power cables are included as part of the system components.

The portfolio includes devices classified as Class I, Class II, and Class III under FDA regulations, with submissions recorded in the 510(k), PMA, and UDI registries. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 70, Commerce Center, Greenville, United States
Website: savariapatientcare.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Taydis Logar
EUDAMED SRN: US-MF-000002745
FDA FEI Number: —
DUNS Number: 125111448

Catalogue (2111)

Page 3 of 43

Device	Model / Reference	Registries	Class	Status
Span-America	SPAN AIDS	FDA UDI	Class I	Active
Span-America	CUSTOM CARE	FDA UDI	Class II	Active
Span-America	Convoluted Cushion	FDA UDI	Class I	Active
PressureGuard®	Easy Air XL	FDA UDI	Class II	Unknown
Span-America	OSKA SPAN CARE	FDA UDI	Class II	Active
MC Healthcare	REXX	FDA UDI	Class II	Active
SureFlex	S-LLF150TG	FDA UDI	Class II	Active
Span-America	GEOMATT	FDA UDI	Class I	Active
Span-America	GEO-MATT CUSHION	FDA UDI	Class I	Active
MC Healthcare	REXX	FDA UDI	Class II	Active
SureFlex 200	S-LLF200TG	FDA UDI	Class II	Active
Span-America	The Topper	FDA UDI	Class II	Active
Span-America	Soft Touch	FDA UDI	Class I	Active
Span-America	APM/ APM II	FDA UDI	Class II	Active
PressureGuard®	APM II	FDA UDI	Class II	Active
Span-America	Span Aids	FDA UDI	Class I	Active
PressureGuard®	APM II	FDA UDI	Class II	Active
Span-America	PRT	FDA UDI	Class I	Active
Span-America	Geomattress	FDA UDI	Class I	Unknown
Span-America	SPAN AIDS	FDA UDI	Class I	Active
GreenLight XPS	0010-0210H	FDA UDI	Class II	Unknown
Span-America	Span Aids	FDA UDI	Class I	Active
Span-America	PressureGuard Span Care Convertible	FDA UDI	Class II	Active
Span-America	The Topper	FDA UDI	Class II	Active
Span-America	Geomattress	FDA UDI	Class I	Active
Span-America	GEOMATTRESS	FDA UDI	Class I	Active
Aura XP	0010-8118R	FDA UDI	Class II	Unknown
Span-America	Geomattress	FDA UDI	Class I	Active
Span-America	HERCULES	FDA UDI	Class II	Active
MC Healthcare	REXX	FDA UDI	Class II	Active
Span-America	GEOMATTRESS	FDA UDI	Class I	Active
PressureGuard®	APM	FDA UDI	Class II	Active
Span-America	Geomattress	FDA UDI	Class I	Unknown
PressureGuard®	APM II	FDA UDI	Class II	Active
Span-America	SPAN-CARE	FDA UDI	Class II	Active
PressureGuard®	Custom Care Convertible	FDA UDI	Class II	Active
Span-America	GEOMATTRESS	FDA UDI	Class I	Active
Span-America	The Topper	FDA UDI	Class II	Unknown
Span-America	GEOMATT	FDA UDI	Class I	Active
Span-America	GEOMATTRESS	FDA UDI	Class I	Active
PressureGuard®	Easy Air XL	FDA UDI	Class II	Active
Span-America	GEOMATTRESS	FDA UDI	Class I	Active
MC Healthcare	ADVANTAGE	FDA UDI	Class II	Active
Span-America	Geomattress	FDA UDI	Class I	Unknown
Span-America	GEOMATT	FDA UDI	Class I	Active
Span-America	Span Aids	FDA UDI	Class I	Active
PressureGuard®	PG Protocol	FDA UDI	Class II	Active
Span-America	Convoluted Rollpack	FDA UDI	Class I	Active
Span-America	Span Aids	FDA UDI	Class I	Active
Span-America	GEOMATT	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (24)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

American Medical Systems, Inc. has 24 recall records initiated between July 28, 2003, and October 15, 2014, all of which are recorded as terminated. The reasons cited include mislabeling of product dimensions, missing or incompatible components, overheating risks, packaging integrity failures under simulated shipping conditions, and discrepancies between carton labeling and internal product specifications. Additional recalls involved potential degradation of resorbable sutures beyond their shelf life, missing parts in surgical systems, and products released without meeting final release criteria.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Oct 15, 2014	Z-0805-2015	—	terminated	During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #
Oct 15, 2014	Z-0806-2015	—	terminated	During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #
Oct 10, 2014	Z-0209-2015	—	terminated	AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.
Mar 1, 2013	Z-1279-2013	—	terminated	American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
Mar 1, 2013	Z-1280-2013	—	terminated	American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
Oct 19, 2012	Z-0259-2013	—	terminated	American Medical Systems (AMS) is issuing a voluntary recall on a number of lots of the AdVance Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the
May 9, 2011	Z-2669-2011	—	terminated	American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa
May 9, 2011	Z-2668-2011	—	terminated	American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa
May 9, 2011	Z-2755-2011	—	terminated	This is an important notification regarding the Elevate Anterior and Apical Prolapse Repair Systems, Part Number 720093-01, manufactured between August 3, 2010 and January 17, 2011. We have recently received complaints stating that the eyelets were missing from the center graft of some units within the scope of this issue. The complaint rate to-date for the affected product is 0.045%, however th
Sep 7, 2010	Z-0808-2011	—	terminated	American Medical Systems (AMS) is recalling all lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013. Internal testing has indicated the potential for degradation of the bioabsorbable tensioning sutures when the product is stored for longer than 15 months after the date of manufacture.
Dec 5, 2008	Z-0932-2009	—	terminated	The product size shown on the carton labeling does not match the size on the product inside.
Jul 17, 2008	Z-2461-2008	—	terminated	The carton labeling does not match the product packaged inside. The package indicated that the device is an 18cm Preconnected MS pump while it is actually an 18cm Ultrex Preconnected MS Pump.
Jan 28, 2008	Z-1235-2008	—	terminated	Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.
Feb 19, 2007	Z-0703-2007	—	terminated	Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
Feb 19, 2007	Z-0702-2007	—	terminated	Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
Feb 9, 2007	Z-0786-2007	—	terminated	The carton labeling does not match the product packaged inside.
Feb 9, 2007	Z-0787-2007	—	terminated	The carton labeling does not match the product packaged inside.
Feb 9, 2007	Z-0785-2007	—	terminated	The carton labeling does not match the product packaged inside.
Feb 9, 2007	Z-0788-2007	—	terminated	The carton labeling does not match the product packaged inside.
Feb 9, 2007	Z-0789-2007	—	terminated	The carton labeling does not match the product packaged inside.
Jan 13, 2006	Z-0675-06	—	terminated	Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.
Apr 29, 2004	Z-0931-04	—	terminated	The product is mislabeled as to length.
Apr 29, 2004	Z-0930-04	—	terminated	The product is mislabeled as to length.
Jul 28, 2003	Z-1019-04	—	terminated	Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.