FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
158593–158616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1982
KM-KAL L4
K823045 · JIX
Kmn Products, Inc.
Chemistry · 21d
Cleared Nov 05, 1982
KM-KAL L5
K823046 · JIX
Kmn Products, Inc.
Chemistry · 21d
Cleared Nov 05, 1982
FLOUROSET IMMUNOFLUORESCENT ANTIBODY
K823055 · DHN
Immulok, Inc.
Immunology · 18d
Cleared Nov 05, 1982
BRUSH, SCRUB, OPERATING ROOM
K823061 · GEC
Seamless Hospital Products Co.
General & Plastic Surgery · 18d
Cleared Nov 05, 1982
ACETAMIDE AGAR SLANT
K823070 · JSH
Granite Diagnostics, Inc.
Pathology · 17d
Cleared Nov 05, 1982
RICE EXTRACT AGAR
K823071 · JSH
Granite Diagnostics, Inc.
Pathology · 17d
Cleared Nov 05, 1982
LECITHIN LACTOSE AGAR
K823072 · JSE
Granite Diagnostics, Inc.
Pathology · 17d
Cleared Nov 05, 1982
H BROTH
K823091 · JSH
Granite Diagnostics, Inc.
Pathology · 17d
Cleared Nov 05, 1982
RESI-WALKER
K823105 · ITJ
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 05, 1982
BRACE-UP STOCKING KNEE BRACE
K823114 · IQI
Arco Matic, Inc.
Physical Medicine · 15d
Cleared Nov 05, 1982
OB TILT TABLE
K823149 · INW
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 05, 1982
SESAM TREATMENT TABLE
K823150 · INQ
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 05, 1982
OB TRIPP TRANSPORT CHAIR
K823151 · INM
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 05, 1982
OB HELP ARM
K823152 · ILE
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 05, 1982
BATH TUB SEAT & BATH BOARD
K823153 · IKX
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 05, 1982
SHOWER STOOL W/HANDLES
K823154 · IKX
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 05, 1982
LAVATORY SEAT HEIGHTENER
K823155 · ILS
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 05, 1982
COLLAPSABLE LAVATORY HEIGHTENER
K823156 · ILS
Orthion Corp.
Physical Medicine · 16d
Cleared Nov 04, 1982
TRIMED 510 APNEA MONITOR
K822819 · BZQ
Tri-Med, Inc.
Anesthesiology · 45d
Cleared Nov 04, 1982
GENERATION 5 LINKOW BLADE IMPLANTS
K822969 · NRQ
Leonard P. Linkow, D.D.L.
Dental · 27d
Cleared Nov 04, 1982
MEDEVICES ASPIRATION HOSE
K823006 · HHK
Berkeley Medevices
Obstetrics & Gynecology · 23d
Cleared Nov 04, 1982
HYPERLUX 30 IMAGE SYSTEM
K827489 · JAA
Cgr Medical Corp.
Radiology
Cleared Nov 03, 1982
VESTIBULARISET
K820775 · ETP
Jedmed Instrument Co.
Ear, Nose, Throat · 225d
Cleared Nov 03, 1982
MALE CONDOM
K822088 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 113d