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
145177–145200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1986
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
K860141 · LAR
American Dade
Toxicology · 28d
Cleared Feb 11, 1986
URIC ACID REAGENT SET (COLORIMETRIC)
K860142 · LFQ
Sterling Diagnostics, Inc.
Chemistry · 28d
Cleared Feb 11, 1986
QWIKSPIN (TM)
K860172 · JQC
Norfolk Scientific, Inc.
Chemistry · 25d
Cleared Feb 11, 1986
ALLEN UNIVERSAL STIRRUP
K860177 · BWN
Edgewater Medical Equipment Systems
General & Plastic Surgery · 25d
Cleared Feb 11, 1986
ALBUMIN REAGENT KIT
K860213 · CIX
Bio-Analytics Laboratories, Inc.
Chemistry · 20d
Cleared Feb 11, 1986
MAGNESIUM REAGENT SET
K860215 · JGJ
Sterling Diagnostics, Inc.
Chemistry · 20d
Cleared Feb 11, 1986
METRICOM
K860225 · LDK
Far Orthopedics, Inc.
Physical Medicine · 20d
Cleared Feb 11, 1986
AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA
K860251 · CEC
Amersham Corp.
Chemistry · 18d
Cleared Feb 11, 1986
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA
K860252 · CDP
Amersham Corp.
Chemistry · 18d
Cleared Feb 11, 1986
XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
K860285 · KNT
Vygon Corp.
Gastroenterology & Urology · 14d
Cleared Feb 11, 1986
TOTAL PROTEIN (BIURET) REAGENT SET
K860341 · CEK
Sterling Diagnostics, Inc.
Chemistry · 13d
Cleared Feb 11, 1986
ALKALINE PHOSPHATASE REAGENT SET
K860351 · CIO
Sterling Diagnostics, Inc.
Chemistry · 12d
Cleared Feb 11, 1986
CREATININE REAGENT SET
K860418 · CGX
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared Feb 11, 1986
UREA NITROGEN REAGENT SET
K860419 · CDW
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared Feb 11, 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
K860421 · CDX
American Dade
Chemistry · 7d
Cleared Feb 10, 1986
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500
K854406 · JQW
Tecan U.S., Ltd.
Chemistry · 101d
Cleared Feb 10, 1986
STUART GILMAN'S WEIGHT LOSS PLAN
K854441 · LDQ
Alpha Therapeutic Corp.
General & Plastic Surgery · 97d
Cleared Feb 10, 1986
LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM
K854465 · JDI
Link America, Inc.
Orthopedic · 96d
Cleared Feb 10, 1986
VENOUS RETURN CANNULA W/CUFF 91039
K854487 · DWF
Dlp, Inc.
Cardiovascular · 94d
Cleared Feb 10, 1986
ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET
K854511 · DQX
Electro-Catheter Corp.
Cardiovascular · 90d
Cleared Feb 10, 1986
DEMAND FLOW VALVE & SONRA W/NASAL MASK
K854571 · CBN
Gale E. Dryden
Anesthesiology · 88d
Cleared Feb 10, 1986
MODIFIED CORONARY CARDIOPLEGIA ADAPTOR
K854640 · DWF
Shiley, Inc.
Cardiovascular · 83d
Cleared Feb 10, 1986
ANGIOMED URETERAL STONE DISLODGERS
K854652 · FFL
Angiomed U.S., Inc.
Gastroenterology & Urology · 83d
Cleared Feb 10, 1986
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
K854734 · DRM
Medasonics, Inc.
Cardiovascular · 77d