American Medical Systems, Inc.
American Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1979, most recent 2013, with 6 FDA device recalls on record.
Top product codes for American Medical Systems, Inc.
FDA recalls by American Medical Systems, Inc.
- Z-0805-2015 — AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless steel, curved needle passers. The tip portion of each needle passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. The system also contains a sling assembly including one piece of loosely knitted polypropylene mesh, two removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
- Z-0806-2015 — AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One end of each helical needle passer is keyed to allow a secure attachment of the sling connectors. The sling mesh is constructed of polypropylene monofilament mesh that is precut to 1.2 centimeters arm width, 3.55 centimeters center width, and 35.5 centimeters length. Two absorbable tensioning sutures are threaded into the length of the mesh. Plastic sheaths are placed over each arm of the mesh to aide in ease of placement. The connectors are attached to the ends of the helical needle passers during the procedure. The mesh and suture portions of the sling are intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
- Z-0209-2015 — AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
- Z-1280-2013 — AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.
- Z-1279-2013 — AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.
- Z-0259-2013 — AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by American Medical Systems, Inc.
- K132655 — RETROARC RETROPUBIC SLING SYSTEM
- K112842 — AMS ELEVATE PC
- K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
- K092735 — GREENLIGHT XPS LASER SYSTEM
- K090934 — PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
- K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
- K082677 — AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
- K082730 — AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
- K082006 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- K081613 — SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
- K073219 — WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
- K080185 — AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
- K073703 — AMS MINIARC SLING SYSTEM
- K071902 — AMS MINIARC SLING SYSTEM
- K070993 — TOPAS SYSTEM
- K070065 — AMS SINGLE INCISION SLING SYSTEM (SIS-0)
- K063713 — AMS SMART SLING SYSTEM
- K053371 — AMS MALE TRANSOBTURATOR SLING SYSTEM
- K051485 — AMS PELVIC FLOOR REPAIR SYSTEM
- K051530 — MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.
- K050445 — AMS COLLAGEN DERMAL MATRIX
- K042592 — INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
- K041948 — SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
- K040623 — AMS PERIGEE SYSTEM
- K040537 — AMS APOGEE VAULT SUSPENSION SYSTEM
- K040521 — MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
- K040538 — BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
- K033636 — AMS LARGE PORE POLYPROPYLENE MESH
- K030123 — BIOARC SP SLING KIT
- K023516 — MONARC SLING SYSTEM
- K021263 — MODIFICATION TO SPARC SLING SYSTEM
- K020663 — MODIFICATION TO SPARC SLING SYSTEM
- K020446 — MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
- K013355 — SPARC SLING SYSTEM
- K012342 — AMS SOFT-TISSUE APPROXIMATION SYSTEM
- K011251 — SPARC SLING SYSTEM
- K011910 — IN-FAST BONE SCREW SYSTEM
- K010990 — AMS SLING FIXATION SYSTEM
- K010931 — AMS SACRAL COLPOPEXY SLING, MODEL 72403501
- K010277 — AMS FASCIAL-ANCHORING SYSTEM
- K002721 — AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
- K000279 — STAPLETAC2 BONE ANCHOR SYSTEM
- K991314 — COAGULOOP
- K972091 — AMS FOREIGN BODY EXTRATOR
- K971512 — AMS COAGULOOP RESECTION ELECTRODE
- K971332 — AMS MAINSTAY UROLOGIC BONE ANCHOR
- K963328 — AMS AMBICOR PENILE PROSTHESIS
- K951716 — AMS 650 MALLERABLE PENIEL PROSTHESIS
- K942578 — ENTRAC URETERAL BALLOON DILATATION CATHETERS
- K940542 — NAMIC ARIA(TM) INFLATION DEVICE
- K920551 — 120 FR OPTILUME PROSTATE BALLOON DILATOR
- K921839 — ENTRAC URETERAL BALLOON DILATION CATHETERS
- K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER
- K914905 — ENTRAC(TM) URETHRAL MEASURING CATHETER
- K912934 — AMS SPHINCTER 800 URINARY PROSTHESIS
- K912935 — AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
- K901482 — 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
- K900760 — AMS OPTILUME INFLATION SYRINGE
- K900761 — AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
- K896941 — AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
- K882297 — 1/2 CM REAR TIP EXTENDER (RTE)
- K852389 — URETERAL STENT
- K833583 — VERIFORM II
- K831660 — AMS MALLEABLE PENILE PROSTHESIS
- K830048 — INFLATABLE PENILE PROSTH. - CYLINDER
- K821627 — THE ARTIFICIAL URINARY SPHINCTER
- K821628 — THE INFLATABLE PENILE PROSTHESIS
- K822143 — TOMAC LUBRICATING JELLY
- K820814 — THERMO-K
- K792724 — AMS MALLEABLE OR JONAS SILICONE-SILVER
- K790519 — ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
Data sourced from openFDA. This site is unofficial and independent of the FDA.