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
159505–159528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1982
SIEMENS-ELEMA AB AGA REVIVATOR
K822213 · BTM
Siemens Elema AB
Anesthesiology · 94d
Cleared Oct 28, 1982
RI 300 DIFFERENTIAL TEMPERATURE MONITOR
K822831 · FLL
Instrumentation Industries, Inc.
General Hospital · 37d
Cleared Oct 28, 1982
PLEUR-EVAC A-4005 SYSTEM
K823037 · GCX
Howmedica Corp.
General Hospital · 14d
Cleared Oct 27, 1982
GELRITE
K820610 · JSK
Kelco
Microbiology · 233d
Cleared Oct 27, 1982
TYMPANOSTOMY TUBES & VARIOUS TYPES
K822017 · ETD
Kelleher Corp.
Ear, Nose, Throat · 111d
Cleared Oct 27, 1982
TPK 1980/1
K822449 · LCX
Plantex USA, Inc.
Chemistry · 72d
Cleared Oct 27, 1982
TOXOPLASMA GONDII ANTIBODY IGG
K822605 · LJK
Immulok, Inc.
Microbiology · 61d
Cleared Oct 27, 1982
MICROFLUOR READER
K822772 · KHO
Dynatech Corp.
Chemistry · 43d
Cleared Oct 27, 1982
PICOLITE
K822800 · JJQ
United Technologies Packard
Chemistry · 40d
Cleared Oct 27, 1982
CONTAINERS OF STERILE WATER OS SALINE
K822811 · BTO
American Pharmaseal Div. Ahsc
Anesthesiology · 37d
Cleared Oct 27, 1982
HISH EIA DIAGNOSTIC KIT
K822827 · JLW
Abbott Laboratories
Chemistry · 36d
Cleared Oct 27, 1982
RADIOIMMUNOASSAY, HUMAN CHORRIONIC
K822840 · JHI
Bioclinical Group
Chemistry · 34d
Cleared Oct 27, 1982
SOPHEIA CORTISOL EIA KIT
K822845 · CGR
Diagnostic Products Corp.
Chemistry · 34d
Cleared Oct 27, 1982
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
K822850 · JJY
American Dade
Chemistry · 34d
Cleared Oct 27, 1982
TRIGLYCERIDE CALIBRATOR
K822852 · JIT
Harleco Diagnostics
Chemistry · 33d
Cleared Oct 27, 1982
RIA SSIST TI-59 MAGNETIC CARD PROGRAMS
K822860 · JQP
Ventrex Laboratories, Inc.
Chemistry · 30d
Cleared Oct 27, 1982
URIC ACID 75CDO
K822884 · CDO
Technicon Instruments Corp.
Chemistry · 29d
Cleared Oct 27, 1982
GONORRHEA TRANSETTE 3
K822886 · JSM
Spectrum Diagnostic, Inc.
Microbiology · 29d
Cleared Oct 27, 1982
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA
K822933 · LEG
Syva Co.
Chemistry · 23d
Cleared Oct 27, 1982
SYVA ADVANCE EMIT AED VALPROIC ACID CONT
K822934 · LAS
Syva Co.
Toxicology · 23d
Cleared Oct 27, 1982
ELLISON VITALLIUM FIXATION STAPLE SYS
K822943 · JDR
Howmedica Corp.
Orthopedic · 23d
Cleared Oct 27, 1982
MIDAS 1000 WRIGHT STAIN #66010
K822980 · IAF
Emd Chemicals, Inc.
Hematology · 19d
Cleared Oct 27, 1982
MIDAS 1000 WRIGHT GIEMSA STAIN #66020
K822981 · IAF
Emd Chemicals, Inc.
Hematology · 19d
Cleared Oct 27, 1982
MIDAS 100 HEMACOLOR STAIN #66030
K822982 · HYB
Emd Chemicals, Inc.
Hematology · 19d