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
155809–155832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1983
ENEMA TUBE
K832501 · KNT
Cone Instruments, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 31, 1983
RECLINING WHEELS
K832511 · INN
Reclining Wheels
Physical Medicine · 35d
Cleared Aug 31, 1983
MONOJET SAMPLETTE ADAPTERS
K832578 · GIO
Sherwood Medical Co.
Hematology · 29d
Cleared Aug 31, 1983
VESSEL DILATOR
K832595 · DWP
Abbott Laboratories
Cardiovascular · 29d
Cleared Aug 26, 1983
FR ROOT CANAL FILLER
K830763 · KIF
Shizai Corp.
Dental · 169d
Cleared Aug 26, 1983
HEMOPERFUSION SYSTEM TP-400
K831029 · FLD
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 149d
Cleared Aug 26, 1983
P.C.A. HIP SYSTEM
K831373 · JDI
Howmedica Corp.
Orthopedic · 121d
Cleared Aug 26, 1983
TACTIL EAR
K831501 · LRA
Ear Three Systems
Ear, Nose, Throat · 107d
Cleared Aug 26, 1983
COLLINS EAGLE II
K831779 · BZC
Warren E. Collins, Inc.
Anesthesiology · 85d
Cleared Aug 26, 1983
RAICHEM ACID PHASPHATASE REAGENT
K831834 · CKB
Reagents Applications, Inc.
Chemistry · 80d
Cleared Aug 26, 1983
FIAX CRP TEST KIT
K832054 · DCK
Intl. Diagnostic Technology
Immunology · 60d
Cleared Aug 26, 1983
ROBIN CORDLESS HANDPIECE
K832063 · EKX
Kaycor Intl., Ltd.
Dental · 60d
Cleared Aug 26, 1983
COATEST FACTOR X
K832114 · GGP
Kabivitrum, Inc.
Hematology · 57d
Cleared Aug 26, 1983
MARK III OXYGEN WALKER SYS. RESERVOIR
K832143 · BYJ
Linde Div. Union Carbide Corp.
Anesthesiology · 52d
Cleared Aug 26, 1983
CLIRANS TAF06 HOLLOW FIBER DIALYZER
K832252 · KOC
Terumo Medical Corp.
Gastroenterology & Urology · 46d
Cleared Aug 26, 1983
VISI-FLOW IRRIGATOR
K832299 · EXD
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 44d
Cleared Aug 26, 1983
ONPG DISCS
K832307 · JTO
Oxoid U.S.A., Inc.
Microbiology · 43d
Cleared Aug 26, 1983
PHOTON IMMUNOASSAY ANALYZER
K832364 · JJQ
Hybritech, Inc.
Chemistry · 39d
Cleared Aug 26, 1983
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
K832408 · LCR
American Dade
Chemistry · 36d
Cleared Aug 25, 1983
DISPOSABLE SCISSORS
K831661 · KDC
Medcare Products
General & Plastic Surgery · 94d
Cleared Aug 24, 1983
IMMOBILINE SYSTEM LKB 1819
K830797 · JJN
Lkb Instruments, Inc.
Chemistry · 163d
Cleared Aug 24, 1983
BUTTON INFUSER
K831063 · FMI
Markwell Medical Institute, Inc.
General Hospital · 142d
Cleared Aug 24, 1983
HS-100 HEADSPACE SAMPLING ACCESSORY
K831387 · KZQ
The Perkin-Elmer Corp.
Toxicology · 118d
Cleared Aug 24, 1983
INTRAOPERATIVE AUTOTRANSFUSION SYS
K831557 · CAC
Thoratec Laboratories Corp.
Anesthesiology · 100d