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
167521–167544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1980
VENTED I.V. SET
K792228 · FPA
Abbott Laboratories
General Hospital · 72d
Cleared Jan 16, 1980
MODEL 7620 LINE CLAMP
K792277 · KOC
B-D Drake Willock
Gastroenterology & Urology · 64d
Cleared Jan 16, 1980
BAKER INTESTINAL TUBE, TWIN CUFF
K792333 · KNT
Intl. Hospital Products, Inc.
Gastroenterology & Urology · 58d
Cleared Jan 16, 1980
CENTRIA LH RIA
K792350 · CEP
Union Carbide Corp.
Chemistry · 58d
Cleared Jan 16, 1980
ELVI-AMINOLEVULINIC ACID
K792407 · DIJ
Volu Sol Medical Industries
Toxicology · 51d
Cleared Jan 16, 1980
C-DAK 2100 ARTIFICIAL KIDNEY
K792419 · FJI
Cordis Corp.
Gastroenterology & Urology · 50d
Cleared Jan 16, 1980
DISPOSABLE TEMPERATURE PROBE
K792426 · FLK
Hospitak, Inc.
General Hospital · 49d
Cleared Jan 16, 1980
RIA-QUANT CK-MB TEST KIT
K792504 · JHX
Mallinckrodt Critical Care
Chemistry · 43d
Cleared Jan 16, 1980
CK-MB (CREATINE KINASE-MB) RIA CONTROL
K792524 · JJX
Mallinckrodt Critical Care
Chemistry · 41d
Cleared Jan 16, 1980
NEOCHROME II GLUCOSE, #4044
K792534 · CGA
American Monitor Corp.
Chemistry · 40d
Cleared Jan 16, 1980
TRIIODOTHYRONINE RIA SYSTEM
K792539 · CDP
Radioimmunoassay, Inc.
Chemistry · 37d
Cleared Jan 16, 1980
PONCEAU S STAIN SET
K792550 · KQC
Electrophoresis Corp. of America
Hematology · 37d
Cleared Jan 16, 1980
ELVI MUCAPROTEINS
K792554 · JQN
Volu Sol Medical Industries
Chemistry · 37d
Cleared Jan 16, 1980
ELVI NON-ESTERIFIED FATTY ACIDS
K792555 · JLH
Volu Sol Medical Industries
Chemistry · 37d
Cleared Jan 16, 1980
NASO STENT
K792556
Tripedsil, Inc.
General & Plastic Surgery · 40d
Cleared Jan 16, 1980
SPECTROPHATOMETER MODELS 2280 & 2380AA
K792557 · JXR
The Perkin-Elmer Corp.
Toxicology · 37d
Cleared Jan 16, 1980
IMMUNOSTAT TSH TEST
K792562 · JLW
Meloy Laboratories, Inc.
Chemistry · 35d
Cleared Jan 16, 1980
GENERAL ELECTRIC PANELIPSE LD
K792581 · EHD
General Electric Co.
Radiology · 33d
Cleared Jan 16, 1980
POLY-LEC SYSTEM
K792582 · KSI
Gamma Biologicals, Inc.
Hematology · 33d
Cleared Jan 16, 1980
GAMMA ARACHIS HYPOGEA LECTIN
K792583 · KSI
Gamma Biologicals, Inc.
Hematology · 33d
Cleared Jan 16, 1980
TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY
K792599 · CDX
Nuclear Diagnostics, Inc.
Chemistry · 29d
Cleared Jan 16, 1980
CHLORIDE REAGENT
K792605 · CHJ
Gilford Diagnostics
Chemistry · 29d
Cleared Jan 16, 1980
T3 UPTAKE (T3U) REAGENTS
K792607 · KHQ
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 29d
Cleared Jan 16, 1980
STERILIZATION PROCESS/PLACENTA BASIN
K792625 · FNY
Procter & Gamble Mfg. Co.
General Hospital · 28d