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
172873–172896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1977
TSH RIA TEST SYSTEM
K771222 · JLW
Monobind
Chemistry · 30d
Cleared Aug 04, 1977
EMERGENCY OXYGEN RESUSCITATOR
K771299 · BTL
Fraser Sweatman, Inc.
Anesthesiology · 21d
Cleared Aug 04, 1977
DIGITAL RADIATION DETECTOR
K771301 · IZD
Actus, Inc.
Radiology · 20d
Cleared Aug 04, 1977
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · GIM
Organon, Inc.
Hematology · 21d
Cleared Aug 04, 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
K771305 · GIM
Organon, Inc.
Hematology · 21d
Cleared Aug 04, 1977
BAIN BREATHING CIRCUIT
K771307 · CAI
Respiratory Care, Inc.
Anesthesiology · 17d
Cleared Aug 04, 1977
BICHROMATIC ANALYZER ABA-200
K771345 · JJE
Abbott Laboratories
Chemistry · 15d
Cleared Aug 04, 1977
ECG SCOPE MODEL 7833
K771360 · DRT
Hewlett-Packard Co.
Cardiovascular · 10d
Cleared Aug 04, 1977
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A
K771361 · DRS
Hewlett-Packard Co.
Cardiovascular · 10d
Cleared Aug 04, 1977
PORTABLE INFANT VENTILATOR
K771368 · FOC
Cavitron Corp.
Gastroenterology & Urology · 10d
Cleared Aug 04, 1977
SCREENING COMPUTEO SC-20
K771371 · BZM
Cavitron Corp.
Anesthesiology · 10d
Cleared Aug 04, 1977
SYSTEM II
K771372 · DSF
Irex Corp.
Cardiovascular · 10d
Cleared Aug 04, 1977
SCANNER TREND SYSTEM
K771374 · DSI
Instruments For Cardiac Research
Cardiovascular · 10d
Cleared Aug 04, 1977
2 JET SET
K771385 · BYF
Bd Becton Dickinson Vacutainer...
Anesthesiology · 8d
Cleared Aug 04, 1977
LUNG VOLUME & PRESSURE MONITOR
K771407 · BZQ
Research Development Corp.
Anesthesiology · 6d
Cleared Aug 04, 1977
WROUGHT (FORGED) VITALLIUM
K771408 · LZN
Howmedica Corp.
Orthopedic · 6d
Cleared Aug 04, 1977
PREGELLED DISP. EKG MONITORING ELECT-
K771447 · DRX
Hayes Products, Inc.
Cardiovascular · 2d
Cleared Aug 03, 1977
X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC
K770693 · IZH
Xonics Medical Systems, Inc.
Radiology · 112d
Cleared Aug 03, 1977
API 20C
K771008 · JXB
Analytical Products, Inc.
Microbiology · 61d
Cleared Aug 03, 1977
IMPREFLEX ALGINATE IMPRESSION MATERIAL
K771120 · LEW
Espe Dental Products
Toxicology · 42d
Cleared Aug 03, 1977
EMPTY ADMIXTURE CONTAINERS
K771121 · KPE
Medi, Inc.
General Hospital · 42d
Cleared Aug 03, 1977
GAMMA GOUNTING SYS., AUTO, MODEL 1400
K771180 · JJJ
G.D. Searle and Co.
Immunology · 34d
Cleared Aug 03, 1977
FETAL/MATERNAL ALRM MODULE - 21595A
K771194 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 33d
Cleared Aug 03, 1977
FETAL/MATERNAL REPEATER - 21596A
K771195 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 33d