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
173089–173112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1977
EMATOLOGY DILUENT RESERVOIR CLOSURE
K770980 · GHO
Bd Becton Dickinson Vacutainer...
Hematology · 41d
Cleared Jul 11, 1977
LANCER CAPILLARY BLOOD SERUM SEPARATOR
K770981 · GIO
Sherwood Medical Industries
Hematology · 41d
Cleared Jul 11, 1977
STATZYME GLUCOSE
K771001 · CGA
Worthington Biochemical Corp.
Chemistry · 38d
Cleared Jul 11, 1977
VYGON RED-O-PACK
K771015 · GCY
Coastal Bend Medical Products, Inc.
General & Plastic Surgery · 35d
Cleared Jul 11, 1977
HSV TEST
K771063 · GQL
Gull Laboratories, Inc.
Microbiology · 28d
Cleared Jul 11, 1977
CATHETER, SAMPLING, CONDUIT
K771066 · FEZ
Mentor Corp.
Gastroenterology & Urology · 28d
Cleared Jul 11, 1977
UNIPAK HEMOGLOBIN
K771090 · GKK
Harleco
Chemistry · 25d
Cleared Jul 11, 1977
COUNTER 700 & HC-700 HEMO 0 REF.
K771107 · GKL
Hycel, Inc.
Hematology · 21d
Cleared Jul 11, 1977
CENTRIA SEPARATION COLUMNS TYPE A
K771118 · CEM
Clinical Diagnostics, Inc.
Immunology · 20d
Cleared Jul 11, 1977
INORGANIC PHOSPHORUS STANDARDS
K771143 · JIT
Worthington Biochemical Corp.
Hematology · 14d
Cleared Jul 11, 1977
DERMAHOOK #382-805
K771187 · GDG
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Jul 11, 1977
HOT TEMP CAUTERY
K771189 · HQP
Edward Weck, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1977
ABRAMSON TRACHEA HOOK & RETRACTOR
K771190 · GDG
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Jul 11, 1977
HEISS RETRACTOR
K771191 · GAD
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Jul 11, 1977
LOWMAN BONE FORCEP
K771192 · HTD
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Jul 11, 1977
UROGARD URINARY DRAINAGE BAG
K771210 · FCN
Terumo America, Inc.
Gastroenterology & Urology · 6d
Cleared Jul 06, 1977
LABORATORY EXPENDABLE PRODUCTS
K770594 · JRC
Abco Dealers, Inc.
Chemistry · 100d
Cleared Jul 06, 1977
FLUORESCENCE ILLUMINATOR ACCESSORY
K770652 · IBK
Bausch & Lomb, Inc.
Pathology · 91d
Cleared Jul 05, 1977
NEBULIZER
K770664 · CAF
J & S Industries, Inc.
Anesthesiology · 89d
Cleared Jul 05, 1977
REAGENT KIT, ENZYMATIC AMYLASE
K770750 · JFJ
Beckman Instruments, Inc.
Chemistry · 71d
Cleared Jul 05, 1977
IN VITRO DIAG. FOR URIC ACID
K770767 · CDO
Smithkline Diagnostics, Inc.
Chemistry · 68d
Cleared Jul 05, 1977
TUBE, STAIN, RETICULOCYTE, LARC
K770792 · KFC
Corning Medical & Scientific
Hematology · 64d
Cleared Jul 05, 1977
HEMOTOLOGY PRODU&TS (5 IN ALL)
K770803 · GKK
Hycel, Inc.
Chemistry · 64d
Cleared Jul 05, 1977
SPIROMETEO EXHAUST
K770907 · BZK
Timeter Instrument Corp.
Anesthesiology · 48d