Medical Device Manufacturer · US , Mchenry , IL

Downs Surgical , Ltd.

60 submissions · 60 cleared · Since 1980
60
Total
60
Cleared
0
Denied

Downs Surgical , Ltd. — FDA 510(k) Submissions

Downs Surgical , Ltd. has submitted 60 FDA 510(k) premarket notifications since 1980, of which 60 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Arthroscope, Needle, Aspiration And Injection, Reusable, Instrument, Surgical, Non-powered, Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component), Speculum, Vaginal, Metal . Use the specialty filter in the sidebar to narrow results.

60 devices
1–25 of 60
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U
K903747 · GDM Needle, Aspiration And... · General & Plastic Surgery
Oct 1990 76d
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V
K903748 · GDM Needle, Aspiration And... · General & Plastic Surgery
Oct 1990 76d
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U
K903749 · GDM Needle, Aspiration And... · General & Plastic Surgery
Oct 1990 76d
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E
K903750 · GDM Needle, Aspiration And... · General & Plastic Surgery
Oct 1990 76d
SHEPPERD LUMBAR DISCECTOMY SYSTEM
K900608 · HRX Arthroscope · Orthopedic
Oct 1990 256d
SHEPPERD STRAIGHT AND CURVED NEEDLES
K900609 · HRX Arthroscope · Orthopedic
Oct 1990 256d
SHEPPERD CANNULA STILLETTE & OBDURATOR SET
K900610 · HRX Arthroscope · Orthopedic
Oct 1990 256d
SHEPPERD DILATATION TUBE SET (GS-501-20-H)
K900611 · HRX Arthroscope · Orthopedic
Oct 1990 256d
SHEPPERD TREPHINE SET (GS-501-30-V)
K900612 · HRX Arthroscope · Orthopedic
Oct 1990 256d
SHEPPERD SHELTER TUBE COMPLETE & DRILL
K900613 · HRX Arthroscope · Orthopedic
Oct 1990 256d
SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V)
K900614 · HRX Arthroscope · Orthopedic
Oct 1990 256d
SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE
K900615 · HRX Arthroscope · Orthopedic
Oct 1990 256d
SHEPPERD CUTTING FORCEPS
K900616 · HRX Arthroscope · Orthopedic
Oct 1990 256d
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · ETN Stimulator, Nerve · Ear, Nose, Throat
Jul 1988 81d
NEW SIZES SUGITA CLIPS
K881911 · HCI Applier, Aneurysm Clip · Neurology
Jun 1988 28d
SANO CLIP APPLIERS & REMOVERS
K881912 · HCI Applier, Aneurysm Clip · Neurology
Jun 1988 28d
MALLEABLE PTFE COATED BRAIN SPATULAE
K880278 · HAO Instrument, Surgical,... · Neurology
Feb 1988 20d
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
K874630 · HAO Instrument, Surgical,... · Neurology
Dec 1987 43d
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM
K873933 · GZX Instrument, Microsurgical · Neurology
Dec 1987 83d
RANGE OF CROCODILE ACTION INSTRUMENTS
K873934 · GZX Instrument, Microsurgical · Neurology
Dec 1987 83d
MODIFIED HUCKSTEP INTRAMEDULLARY NAIL
K871947 · HSB Rod, Fixation,... · Orthopedic
Aug 1987 78d
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
K871956 · KWA Prosthesis, Hip,... · Orthopedic
Jun 1987 34d
WARD'S BREAST MEASURING DEVICE
K870887 · General & Plastic Surgery
Mar 1987 26d
RING UPM TOTAL HIP REPLACEMENT
K864515 · KWA Prosthesis, Hip,... · Orthopedic
Mar 1987 116d
MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE.
K864631 · Orthopedic
Dec 1986 23d
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