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
155329–155352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1983
PERCUTANEOUS TRACHEOSTOMY DEVICE
K832498 · BTO
Frederic J. Toye, M.D.
Anesthesiology · 79d
Cleared Oct 14, 1983
CEFUROXIME 30 MCG SENSI-DISC
K832515 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 78d
Cleared Oct 14, 1983
CUSTOM KWIK SET AND/OR PAK
K832517 · JOL
Norton Texas Medical Products
General Hospital · 78d
Cleared Oct 14, 1983
MARK V HIGH VOLTAGE GALVANIC STIMULATORR
K832546 · IPF
Orthion Corp.
Physical Medicine · 77d
Cleared Oct 14, 1983
MOUTH-TO-MOUTH SHIELD APPLICATOR
K832590 · LAE
Mem, Inc.
Toxicology · 73d
Cleared Oct 14, 1983
TOP DISPOSABLE PLASTIC SYRINGES
K832621 · FMF
Top Surgical Manufacturers Co.
General Hospital · 71d
Cleared Oct 14, 1983
WINGED INFUSION SET
K832622 · FPA
Top Surgical Manufacturers Co.
General Hospital · 71d
Cleared Oct 14, 1983
TOP DISPOS. INFUSION SET/HEMODIALY
K832623 · KOC
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 71d
Cleared Oct 14, 1983
TOP STERILE DISPOS. HYPODERMIC NEEDLES
K832626 · GAA
Top Surgical Manufacturers Co.
General & Plastic Surgery · 71d
Cleared Oct 14, 1983
FRAZIER SUCTION INSTRUMENT-DISPOS
K832636 · GEA
Pilling Co.
General & Plastic Surgery · 71d
Cleared Oct 14, 1983
CEFUROXIME 30MCG. SUSCEP DISK
K832653 · JTN
General Diagnostics
Microbiology · 67d
Cleared Oct 14, 1983
NEPHROSS PRESTO
K832666 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 66d
Cleared Oct 14, 1983
MICRO-EDGE DISPOSABLE BLADES
K832680 · KDC
Micromedics, Inc.
General & Plastic Surgery · 66d
Cleared Oct 14, 1983
MULTIPLE MANUAL SURGICAL INSTRUMENTS
K832686 · HTO
Hirata Sangyo Co. USA, Inc.
Orthopedic · 73d
Cleared Oct 14, 1983
PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS
K832708 · CIC
American Dade
Chemistry · 63d
Cleared Oct 14, 1983
KEMTEK 400 RIA GAMMA COUNTER
K832734 · JJJ
Kemble Instruments, Inc.
Chemistry · 71d
Cleared Oct 14, 1983
ALBUMIN REAGENT SET
K832747 · CIX
Biorent Diagnostic, Inc.
Chemistry · 60d
Cleared Oct 14, 1983
COMPUR* EASYTOUCH TOTAL BILIRUBIN
K832748 · CIG
Worthington Diagnostic Systems
Chemistry · 60d
Cleared Oct 14, 1983
EASYTOUCH BUN REAGENT SET
K832749 · CDQ
Worthington Diagnostic Systems
Chemistry · 60d
Cleared Oct 14, 1983
TOTAL IRON-BINDING CAPACITY ACCESORY
K832759 · JMO
Seragen Diagnostics, Inc.
Chemistry · 56d
Cleared Oct 14, 1983
RIA SOFTWARE
K832760 · JQP
Kemble Instruments, Inc.
Chemistry · 56d
Cleared Oct 14, 1983
REFEREE BLOOD GAS ANALYZER-ELECTRODES
K832779 · CHL
Analytical Products, Inc.
Chemistry · 59d
Cleared Oct 14, 1983
FLOW-PAC SHOLESTEROL REAGENT SET
K832780 · CHH
American Research Products Co.
Chemistry · 59d
Cleared Oct 14, 1983
COMPUR* EASY TOUCH URIC ACID REAGENT
K832785 · KNK
Worthington Diagnostic Systems
Chemistry · 59d