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
143329–143352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1986
S&W TYPE 888 ELECTRODE
K861158 · DRX
National Medical Technology
Cardiovascular · 95d
Cleared Jul 01, 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172 · LIQ
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 95d
Cleared Jul 01, 1986
CHOLESTEROL CALIBRATORS
K861314 · JIT
Sigma Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 01, 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384 · FRO
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 78d
Cleared Jul 01, 1986
CAVAFIX, CENTRAL VENOUS CATHETER KIT
K861479 · FOZ
Burron Medical Products, Inc.
General Hospital · 70d
Cleared Jul 01, 1986
CREATININE PROCEDURE
K861655 · CGX
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
INORGANIC PHOSPHORUS PROCEDURE
K861661 · CEO
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
AMYLASE PROCEDURE
K861664 · CIJ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
BLOOD UREA NITROGEN (BUN) PROCEDURE
K861666 · CDQ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K861670 · CDT
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
BICARBONATE PROCEDURE
K861673 · KHS
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
CHLORIDE PROCEDURE
K861674 · CHJ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
K861696 · JGS
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Jul 01, 1986
MODIFIED MODELS 8320/8322/8329/8316/8317/8318
K861719 · DXY
Medtronic Vascular
Cardiovascular · 60d
Cleared Jul 01, 1986
ERIE-NEB
K861865 · BTI
Erie Medical
Anesthesiology · 47d
Cleared Jul 01, 1986
BYRON SUCTION TIPS
K861878
Byron Medical
General & Plastic Surgery · 47d
Cleared Jul 01, 1986
UNISKAN II
K861897 · JJQ
Flow Laboratories, Inc.
Chemistry · 46d
Cleared Jul 01, 1986
HCG IRMA, CAT. NO. CR-1501
K862007 · JHI
Pacific Biotech, Inc.
Chemistry · 35d
Cleared Jul 01, 1986
SOMAS LIQUID URINE CONTROL
K862179 · JJY
Somas Medical Industries, Inc.
Chemistry · 22d
Cleared Jul 01, 1986
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
K862186 · JPK
Bio-Rad
Hematology · 22d
Cleared Jul 01, 1986
UREA NITROGEN (GLDH) REAGENT SET (UV)
K862210 · CDQ
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Jul 01, 1986
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
K862256 · CJE
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 01, 1986
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS
K862299 · CIG
Amresco, Inc.
Chemistry · 14d
Cleared Jul 01, 1986
FUJITSU MALLEABLE - TIP BRAIN SPATULA
K862331 · HAO
Downs Surgical , Ltd.
Neurology · 12d