Medical Device Manufacturer · US , Mchenry , IL

Ormed Mfg., Inc.

23 submissions · 23 cleared · Since 1983
23
Total
23
Cleared
0
Denied

Ormed Mfg., Inc. — FDA 510(k) Submissions

Ormed Mfg., Inc. has submitted 23 FDA 510(k) premarket notifications since 1983, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gauze/sponge, Internal, Gauze/sponge, Internal, X-ray Detectable, Instrument, Surgical, Disposable, Kit, Surgical Instrument, Disposable, Exerciser, Powered . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
ARTROMOT K2 CPM
K931555 · BXB Exerciser, Powered · Physical Medicine
Jan 1994 307d
GAUZE SPONGE
K882527 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Jul 1988 27d
CYLINDRICAL SPONGE
K882528 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Jul 1988 27d
BUTCHER STRUNG TONSIL SPONGE
K882529 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Jul 1988 27d
TAPE STRUNG TONSIL SPONGE
K882530 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Jul 1988 27d
FLAT STICK SPONGE
K880851 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Mar 1988 16d
ROSEBUD DISSECTORS
K880852 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Mar 1988 16d
CHERRY SPONGE
K880853 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Mar 1988 16d
STRUNG ABSORBENT BALLS
K880854 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Mar 1988 16d
TRIANGLE SPONGE
K880907 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Mar 1988 14d
TRACHEOTOMY SPONGES
K880909 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Mar 1988 14d
ROUND STICK SPONGES
K880910 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Mar 1988 14d
BLUNT SPONGE
K880911 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Mar 1988 14d
EAR AND EYE SPONGES
K873831 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Oct 1987 14d
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
K873391 · GDY Gauze/sponge, Internal,... · General & Plastic Surgery
Sep 1987 18d
STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
K852202 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Jun 1985 36d
PRE-ROLLED TUBULAR STOCKINETTE
K831936 · General & Plastic Surgery
Dec 1983 198d
ROUND-BEEHIVE- DISSECTORS 3/8
K831912 · GDI Dissector, Surgical,... · General & Plastic Surgery
Oct 1983 139d
STRUNG NEURO SPONGE PATTIES-X-RAY-
K831914 · GDY Gauze/sponge, Internal,... · General & Plastic Surgery
Oct 1983 139d
COLOR-EZE PRE-WASHED LAP SPONGES
K831913 · GDY Gauze/sponge, Internal,... · General & Plastic Surgery
Sep 1983 104d
DISPOSABLE FLOOR INSTRUMENTS
K831911 · KDC Instrument, Surgical,... · General & Plastic Surgery
Sep 1983 90d
SAFETY PINS & RUBBER BANDS
K831915 · KDC Instrument, Surgical,... · General & Plastic Surgery
Sep 1983 90d
STERILE SUTURE REMOVAL SET
K832047 · KDD Kit, Surgical Instrument,... · General & Plastic Surgery
Sep 1983 80d
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