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
159601–159624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1982
DIRECT GLUCOSE REAGENT SET
K821198 · CGE
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
CREATININE REAGENT SET
K821199 · CGX
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
ALKALINE PHOSPHOTASE REAGENT SET
K821200 · CIO
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
HDL PRECIPITANT REAGENT SET
K821203 · LBR
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
SERUM TOTAL PROTEIN REAGENT SET
K821210 · CEK
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
URIC ACID REAGENT SET
K821213 · CDH
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
GEMSTAR SYSTEM
K821335 · JJE
Electro-Nucleonics Laboratories, Inc.
Chemistry · 69d
Cleared Jul 13, 1982
LEVEL I LIPID CONTROL
K821559 · JJY
Irvine Scientific
Chemistry · 49d
Cleared Jul 13, 1982
LEVEL II LIPID CONTROL
K821560 · JJY
Irvine Scientific
Chemistry · 49d
Cleared Jul 13, 1982
RIAGEN B-HCG RIA
K821657 · JHI
Biogenex Laboratories
Immunology · 39d
Cleared Jul 13, 1982
PP-100, PERSONAL PERINEOMETER
K821664 · HIR
Farrall Instruments, Inc.
Gastroenterology & Urology · 46d
Cleared Jul 13, 1982
PASSIVE HEAT PADS
K821692 · IRT
Biotone International, Inc.
Physical Medicine · 35d
Cleared Jul 13, 1982
CLINICAL DATA APNEA DETECTOR
K821721 · FLS
Clinical Data, Inc.
Anesthesiology · 33d
Cleared Jul 13, 1982
HEALTHDYNE MODEL 16900 INFANT MONITOR
K821731 · BZQ
Healthdyne, Inc.
Anesthesiology · 42d
Cleared Jul 13, 1982
82 ALLOY
K821798 · EJS
J. Aderer, Inc.
Dental · 25d
Cleared Jul 13, 1982
MCSC6PS MEDICAL COMPONENTS
K821820 · LFL
Medical Components, Inc.
General & Plastic Surgery · 22d
Cleared Jul 13, 1982
A O HISTOSTAT EMBEDDING CTR #8030,32,34
K821831 · IDS
Warner-Lambert Co.
Pathology · 21d
Cleared Jul 13, 1982
THIOGLYCOLLATE MED. W/VITAMIN K-1
K821864 · JSC
Granite Diagnostics, Inc.
Microbiology · 19d
Cleared Jul 13, 1982
ULTRAZYME PLUS AMYL
K821869 · JFJ
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS ALP
K821870 · CJE
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM PHOS
K821874 · CEO
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM TRI-ES
K821875 · CDT
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS GOT
K821876 · CIT
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
REF. ELECTRODE SOL'N.
K821885 · JIX
Avl Scientific Corp.
Chemistry · 18d