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
155737–155760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1983
ALBUMIN PROCEDURE BCP
K832632 · CJW
Sandare Chemical Co., Inc.
Chemistry · 39d
Cleared Sep 12, 1983
CORTISOL RADIOIMMUNOASSAY KIT
K832638 · CGR
Bioclinical Group
Chemistry · 39d
Cleared Sep 12, 1983
ALT -LTS
K832639 · CKA
Electro-Nucleonics Laboratories, Inc.
Chemistry · 39d
Cleared Sep 12, 1983
UPSHER FIBERBRITE LARYNGOSCOPE
K832650 · CCW
Michael S. Upsher
Anesthesiology · 35d
Cleared Sep 12, 1983
GAMMA STERIL. CAPILLARY FLOW DIALY-G15
K832663 · FKQ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 35d
Cleared Sep 12, 1983
FOUR LUMEN BLAKEMORE TUBE
K832672 · KNT
Inmed Corp.
Gastroenterology & Urology · 34d
Cleared Sep 12, 1983
ANA MICROZYME TEST SYS #1610
K832675 · DAA
Clinical Sciences, Inc.
Immunology · 34d
Cleared Sep 12, 1983
MONOJECT INJECTOMATIC
K832683 · KZH
Sherwood Medical Co.
General Hospital · 34d
Cleared Sep 12, 1983
BASAL MED. EAGLE #B9888 W/L-GLUTAMINE
K832687 · KIT
Sigma Chemical Co.
Chemistry · 39d
Cleared Sep 12, 1983
DULBECCO'S MODIFIED EAGLE #D5523-
K832688 · KIT
Sigma Chemical Co.
Chemistry · 39d
Cleared Sep 12, 1983
MCCOY'S 5A #M4892 W/L-GLUTAMINE AND
K832689 · KIT
Sigma Chemical Co.
Chemistry · 39d
Cleared Sep 12, 1983
MINIMUM ESSENTIAL MED. EAGLE M0268
K832690 · KIT
Sigma Chemical Co.
Chemistry · 39d
Cleared Sep 12, 1983
CURITY CATHETER STRAP
K832692 · KOD
The Kendal Co.
Gastroenterology & Urology · 33d
Cleared Sep 12, 1983
EMIT CAD PROCAINAMIDE ASSAY
K832718 · LAR
Syva Co.
Toxicology · 31d
Cleared Sep 12, 1983
RED COLOR-TINTED TUBING
K832758 · FPK
Custom Medical, Inc.
General Hospital · 24d
Cleared Sep 12, 1983
SHERI-I-SLIP INTUBATING STYLET
K832773 · BSR
Sheridan Catheter Corp.
Anesthesiology · 27d
Cleared Sep 09, 1983
C TEC SERIES 9000 E.C.G. ELECTRODE
K831977 · DRX
Speywood Medical, Ltd.
Cardiovascular · 81d
Cleared Sep 08, 1983
DIASTIX REAGENT STRIPS FOR URINALYSIS
K831600 · JIL
Miles Laboratories, Inc.
Chemistry · 113d
Cleared Sep 08, 1983
CODE BLUE MANUAL RESUSCITATOR
K831885 · BTM
Vital Signs, Inc.
Anesthesiology · 87d
Cleared Sep 01, 1983
DAC-CEL HCG-MCA KIT RD52
K831073 · CFL
Wellcome Diagnostics
Chemistry · 150d
Cleared Sep 01, 1983
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441 · MBV
Depuy, Inc.
Orthopedic · 119d
Cleared Sep 01, 1983
FIRST AID KITS
K831795 · KDD
I M, Inc.
General & Plastic Surgery · 90d
Cleared Sep 01, 1983
VIVONEX TUNGSTEN TIP TUBE-BRAIDED
K831968 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 73d
Cleared Sep 01, 1983
VIVONEX TUNGSTEN TIP TUBE-WOUND
K831969 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 73d