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
159961–159984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1982
TANDEM - HGH KIT
K821366 · CFL
Hybritech, Inc.
Chemistry · 31d
Cleared Jun 10, 1982
IL 1302 PH BLOOD GAS ANALYZER
K821483 · CHL
Instrumentation Laboratory CO
Chemistry · 23d
Cleared Jun 10, 1982
DERMABRADERS
K821485 · GFF
Spire Medical, Inc.
General & Plastic Surgery · 23d
Cleared Jun 10, 1982
TITANAN GEL SERUM PROTEIN ELECTROPHORES
K821517 · JJN
Helena Laboratories
Chemistry · 20d
Cleared Jun 10, 1982
ACID PHOSPHATASE REAGENT SET
K821526 · CKE
Anco Medical Reagents & Assoc.
Chemistry · 20d
Cleared Jun 10, 1982
HEMATOXYLIN I
K821533 · HYJ
Volu Sol Medical Industries
Pathology · 20d
Cleared Jun 10, 1982
HEMATOLOGY DATA MANAGEMENT SYS
K821534 · JGP
Biovation, Inc.
Hematology · 17d
Cleared Jun 10, 1982
HEMATOXYLIN II
K821540 · HYJ
Volu Sol Medical Industries
Pathology · 17d
Cleared Jun 10, 1982
HEMATOXYLIN III
K821541 · HYJ
Volu Sol Medical Industries
Pathology · 17d
Cleared Jun 10, 1982
DETECTION OF THEOPHYLLINE
K821544 · KLS
Electro-Nucleonics Laboratories, Inc.
Toxicology · 17d
Cleared Jun 10, 1982
EOSIN Y SOLUTIN, AGUEOUS
K821574 · HYB
Sigma Chemical Co.
Pathology · 14d
Cleared Jun 10, 1982
ANTINUCLEAR ANTIBODY SCREEN FLOURESC
K821576 · DBL
Immuno-Products Industries
Immunology · 13d
Cleared Jun 10, 1982
WARM'N FORM SPORTS SUPPORTS
K821582 · IQI
Jerome Medical
Physical Medicine · 13d
Cleared Jun 10, 1982
VAST VENTREX PD IGE RIA TEST SET
K821615 · DGC
Ventrex Laboratories, Inc.
Chemistry · 8d
Cleared Jun 09, 1982
OUT-RITE WASTE DISPOSABLE BAG
K821396 · LDQ
Kleen Test Products
General & Plastic Surgery · 29d
Cleared Jun 09, 1982
DEVA M
K821407 · EJS
J. Aderer, Inc.
Dental · 29d
Cleared Jun 09, 1982
DEGUDENT 14
K821446 · EJT
J. Aderer, Inc.
Dental · 26d
Cleared Jun 09, 1982
MODEL BERUAFON T85 & T95
K821447 · ESD
Beruafon, Inc.
Ear, Nose, Throat · 26d
Cleared Jun 09, 1982
DYNAMIC FUNTIONAL POSITIONER
K821458 · KMY
Dynamic Functional Positioner, Inc.
Dental · 33d
Cleared Jun 09, 1982
DAWN LOW SPEED HANDPIECE SYSTEM
K821484 · EFB
Young Dental Manufacturing Co. 1, LLC
Dental · 22d
Cleared Jun 09, 1982
MICRO DRILLS
K821486 · GFG
Spire Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jun 09, 1982
CORDIA TG
K821489 · JZO
Cordis Corp.
Chemistry · 22d
Cleared Jun 09, 1982
RIONET HEARING AID
K821508
Rion Acoustic Instruments, Inc.
Gastroenterology & Urology · 19d
Cleared Jun 09, 1982
A THENIUM
K821510 · EJS
Williams Gold Refining Co., Inc.
Dental · 20d