Medical Device Manufacturer · US , Mchenry , IL

Span-America Medical Systems, Inc.

19 submissions · 19 cleared · Since 1980
19
Total
19
Cleared
0
Denied

Span-America Medical Systems, Inc. — FDA 510(k) Submissions

Span-America Medical Systems, Inc. has submitted 19 FDA 510(k) premarket notifications since 1980, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mattress, Air Flotation, Alternating Pressure, Lubricant, Patient, Pad, Alcohol, Device Disinfectant, Cushion, Flotation, Bed, Patient Rotation, Powered . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
PRESSUREGUARD IV
K972486 · IKZ Bed, Patient Rotation,... · Physical Medicine
Feb 1998 233d
PRESSURE GUARD SITE SELECT (A)
K973169 · FNM Mattress, Air Flotation,... · General Hospital
Feb 1998 179d
PRESSUREGUARD: SELECTCARE
K960188 · FNM Mattress, Air Flotation,... · General Hospital
Oct 1996 260d
LUBRICATING JELLY, LOW VISCOSITY
K961502 · KMJ Lubricant, Patient · General Hospital
Jul 1996 90d
POWERED LOW AIR LOSS MATTRESS SYSTEM
K961159 · FNM Mattress, Air Flotation,... · General Hospital
Jun 1996 84d
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
K960620 · FNM Mattress, Air Flotation,... · General Hospital
Apr 1996 72d
GEL-T CUSHION
K960189 · KIC Cushion, Flotation · Physical Medicine
Feb 1996 22d
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K954766 · FNM Mattress, Air Flotation,... · General Hospital
Jan 1996 86d
PRESSUREGUARD IV
K953503 · FNM Mattress, Air Flotation,... · General Hospital
Oct 1995 90d
CUSTOMCARE SEATING SYSTEM
K954117 · KIC Cushion, Flotation · Physical Medicine
Oct 1995 42d
PRESSUREGUARD IV
K951112 · FNM Mattress, Air Flotation,... · General Hospital
Jun 1995 88d
PRESSUREGUARD IV
K932681 · FNM Mattress, Air Flotation,... · General Hospital
Nov 1993 162d
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
K893958 · LKB Pad, Alcohol, Device... · General Hospital
Oct 1989 124d
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE
K894791 · LKB Pad, Alcohol, Device... · General Hospital
Oct 1989 67d
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
K882506 · KMJ Lubricant, Patient · General Hospital
Sep 1988 92d
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
K870742 · KMJ Lubricant, Patient · General Hospital
Jun 1987 100d
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM
K870718 · LKB Pad, Alcohol, Device... · General Hospital
May 1987 76d
SPAN / AID SYRINGE
K854255 · FMF Syringe, Piston · General Hospital
Nov 1985 21d
SPAN-AID BRIDGING PILLOW SYSTEM
K801518 · HKX Tonometer, Ac-powered · Ophthalmic
Aug 1980 34d
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