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
155065–155088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1983
GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL
K833352 · GIL
Warner-Lambert Co.
Hematology · 36d
Cleared Nov 03, 1983
GLYCO-JE,E CPMTRP
K833356 · LCP
Helena Laboratories
Hematology · 36d
Cleared Nov 03, 1983
MRC-5 CELLS
K833358 · KIR
Biocon, Inc.
Hematology · 36d
Cleared Nov 03, 1983
WI-38 CELLS
K833359 · KIR
Biocon, Inc.
Hematology · 36d
Cleared Nov 03, 1983
HEP-2 CELLS
K833360 · KIR
Biocon, Inc.
Hematology · 36d
Cleared Nov 03, 1983
TUBE-TITLE
K833361 · JAY
Sontek Industries, Inc.
Anesthesiology · 37d
Cleared Nov 03, 1983
BODIA TRACH-SAF DOUBLE SWIVEL
K833372 · BZA
Sontek Industries, Inc.
Anesthesiology · 37d
Cleared Nov 03, 1983
BODIA BRONCH-SAF DOUBLE SWIVEL
K833373 · BZA
Sontek Industries, Inc.
Anesthesiology · 37d
Cleared Nov 03, 1983
BITE-BLOCK
K833374 · JAY
Sontek Industries, Inc.
Anesthesiology · 37d
Cleared Nov 03, 1983
MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM
K833389 · KIT
Sigma Chemical Co.
Chemistry · 36d
Cleared Nov 03, 1983
TYRODE'S SALT SOLUTION W/SODIUM BICAR
K833390 · KIT
Sigma Chemical Co.
Chemistry · 36d
Cleared Nov 03, 1983
LACTALBUMIN HYDROLYSATE MED. W/HANKS
K833391 · KIT
Sigma Chemical Co.
Chemistry · 36d
Cleared Nov 03, 1983
WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE
K833392 · KIT
Sigma Chemical Co.
Chemistry · 36d
Cleared Nov 03, 1983
ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM
K833393 · KIT
Sigma Chemical Co.
Chemistry · 36d
Cleared Nov 03, 1983
MEDIUM 199 W/HANK'S SALT W/L-GLUTAMINE
K833394 · KIT
Sigma Chemical Co.
Chemistry · 36d
Cleared Nov 03, 1983
VEIGERT'S IRON HEMATOXYLIN STAIN-HT10-79
K833424 · HYO
Sigma Chemical Co.
Pathology · 31d
Cleared Nov 03, 1983
ORTHOPEDIC STOCKINETTE
K833437 · ILG
Northern Medical Surgical, Inc.
Physical Medicine · 29d
Cleared Nov 03, 1983
ISOTONIC BLOOD CELL DILUENT J & S
K833443 · GIF
Jasins & Sayles Associates, Inc.
Hematology · 29d
Cleared Nov 03, 1983
LYSING & HEMOGLOBIN S-REAGENT J & S
K833444 · GGK
Jasins & Sayles Associates, Inc.
Hematology · 29d
Cleared Nov 02, 1983
PECOR 8.5 FRENCH IAB ON A DATASCOPE
K831307 · DSP
Datascope Corp.
Cardiovascular · 194d
Cleared Nov 02, 1983
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
K831397 · DSP
Datascope Corp.
Cardiovascular · 187d
Cleared Oct 31, 1983
WEIL PERFUSOMETER #100
K830429 · FLL
Wescor, Inc.
General Hospital · 264d
Cleared Oct 31, 1983
GLUCOKEY
K831194 · CGA
Ulster Scientific, Inc.
Hematology · 202d
Cleared Oct 31, 1983
LASTOBAND ADHESIVE BANDAGES
K831454 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 178d