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
171313–171336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1978
DATA-ZYME TRIGLYCERIDE PROCEDURE
K780379 · CDT
Data Medical Associates, Inc.
Chemistry · 65d
Cleared May 12, 1978
POWER STRIDER
K780402 · ITI
Seidel Manufacturing, Inc.
Physical Medicine · 60d
Cleared May 12, 1978
RELAX-A-TONE
K780436 · HCC
Bio Response
Neurology · 56d
Cleared May 12, 1978
ALT(GPT) UNI-UV, SGPT
K780462 · CKA
Sclavo, Inc.
Chemistry · 50d
Cleared May 12, 1978
AST(GOT) UNI-UV, SGOT
K780463 · CIT
Sclavo, Inc.
Chemistry · 50d
Cleared May 12, 1978
SPECTROPHOTOMETER, ATOMIC ABSORPTION
K780521 · JXR
Instrumentation Laboratory CO
Toxicology · 42d
Cleared May 12, 1978
SPECTROPHOTOMETERS, ATOMIC ABSORPTION
K780522 · JXR
Instrumentation Laboratory CO
Toxicology · 42d
Cleared May 12, 1978
FOME-CUF PVC
K780583 · BTR
Bivona Medical Technologies
Anesthesiology · 30d
Cleared May 12, 1978
HEARING AID BATTERY CHARGER
K780694 · ESD
Cahill Enterprises, Inc.
Ear, Nose, Throat · 18d
Cleared May 12, 1978
STIMULATORS, NERVE, ELECTRICAL
K780698 · GZJ
Med General
Neurology · 16d
Cleared May 12, 1978
COLUMBIA AGAR WITH 5% RABBIT BLOOD
K780704 · JSI
Granite Diagnostics, Inc.
Microbiology · 17d
Cleared May 12, 1978
IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST
K780709
Clinical Assays, Inc.
Toxicology · 16d
Cleared May 12, 1978
CULTURE SWAB
K780713 · JRW
Royal Scientific, Inc.
Microbiology · 15d
Cleared May 12, 1978
CLAMP FORCEPS
K780743 · EJG
Hygienic Dental Mfg., Co., The
Dental · 29d
Cleared May 12, 1978
BRINKER TISSUE RETRACTORS
K780744 · EEF
Hygienic Dental Mfg., Co., The
Dental · 29d
Cleared May 12, 1978
RUBBER DAM
K780745 · EIE
Hygienic Dental Mfg., Co., The
Dental · 29d
Cleared May 12, 1978
HYGIENIC RUBBER DAM FRAME
K780746 · EJE
Hygienic Dental Mfg., Co., The
Dental · 29d
Cleared May 12, 1978
SHORTWAVE DIATHERMY MODEL 802
K780755 · IMJ
Birtcher Corp.
Physical Medicine · 4d
Cleared May 09, 1978
CARROLL TENDON RETRIEVER
K772393 · GEN
Edward Weck, Inc.
General & Plastic Surgery · 133d
Cleared May 09, 1978
RYUSEI
K772424 · BWJ
Ercona Corp.
General Hospital · 132d
Cleared May 09, 1978
PHOTOCOAGULATOR LASER
K780345 · HQB
Cavitron Corp.
Ophthalmic · 69d
Cleared May 09, 1978
FETAL MONITORING SYSTEM
K780487 · HFO
Sonicaid, Inc.
Obstetrics & Gynecology · 43d
Cleared May 09, 1978
FILTER TUBE
K780519 · BSN
Jelco Laboratories
Anesthesiology · 39d
Cleared May 09, 1978
MYOCATH KIT
K780529 · DQO
Sorensen Research
Cardiovascular · 36d