Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
160801–160824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1982
DENTRON-EXACT - TRAY
K820997 · EBH
Dentron, Inc.
Dental · 62d
Cleared Jun 10, 1982
DENTRON-DIRECT-TRAY
K820998 · EBH
Dentron, Inc.
Dental · 62d
Cleared Jun 10, 1982
MODEL AS6M INFUSION PUMP
K821069 · FRN
Baxter Healthcare Corp
General Hospital · 55d
Cleared Jun 10, 1982
SPHYGURITE
K821095 · DXQ
Associated Medical Devices, Inc.
Cardiovascular · 52d
Cleared Jun 10, 1982
SELECT BIPOLAR COAGULATION FORCEPS
K821263 · GEI
ZEISS
General & Plastic Surgery · 38d
Cleared Jun 10, 1982
HYPODERMIC NEEDLES & SYRINGES
K821348 · GAA
Medi-Tech, Inc.
General & Plastic Surgery · 36d
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