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
159985–160008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1982
ANTITUBERCULOUS DRUGS (SIRE)
K822329 · JTT
Bd Becton Dickinson Vacutainer...
Microbiology · 30d
Cleared Sep 02, 1982
BACTEC DILUTING FLUID
K822330 · JSD
Bd Becton Dickinson Vacutainer...
Microbiology · 30d
Cleared Sep 02, 1982
BILIRUBIN CALIBRATORS
K822334 · JIT
Gilford Diagnostics
Chemistry · 29d
Cleared Sep 02, 1982
B-HCG
K822343 · JHI
Diagnostic Products Corp.
Chemistry · 28d
Cleared Sep 02, 1982
TYTAN GROMMET VENT TUBE, .040
K822366 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 27d
Cleared Sep 02, 1982
BASIC CENTRIFUGE
K822422 · JQC
Biodynamics Corp.
Hematology · 21d
Cleared Sep 02, 1982
MCINTYRE MICROSCOPE STAND
K822426 · HBN
Surgi-Quip Inc.U
Pathology · 21d
Cleared Sep 02, 1982
SURGI-QUIP MICROSCOPE STAND
K822428 · HBN
Surgi-Quip Inc.U
Pathology · 21d
Cleared Sep 02, 1982
VAST VENTREX RAST ALLERGEN DISCS
K822442 · DGC
Ventrex Laboratories, Inc.
Chemistry · 17d
Cleared Sep 02, 1982
NASO-GARD NASOGASTRIC TUBE HOLDER
K822443 · KNT
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 17d
Cleared Sep 01, 1982
UV SAFETY INFUSER SHIELD
K827453
U.V. Technology, Inc.
Radiology · 42d
Cleared Sep 01, 1982
KODAK KODAFLEX FILM
K827889
Eastman Kodak Company
Radiology · 20d
Cleared Aug 31, 1982
PVP GEL DRESSING
K820635 · FRO
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 176d
Cleared Aug 31, 1982
TRIMMORE ELECTION BEAUTIFIER
K821109 · ISA
Rn Int'L, Inc.
Physical Medicine · 133d
Cleared Aug 31, 1982
GUIDE WIRE
K821190 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 126d
Cleared Aug 31, 1982
BARD PTFE VASCULAR PROSTHESIS
K821716 · DSY
C.R. Bard, Inc.
Cardiovascular · 82d
Cleared Aug 31, 1982
I.C.E. BOX
K821920 · IRP
Lhs Industries
Physical Medicine · 64d
Cleared Aug 31, 1982
INSPIRAID VA-1 VENTILATOR
K822113 · CBK
Inspir Aid
Anesthesiology · 43d
Cleared Aug 31, 1982
MOTORIZED EXERCISER
K822212 · BXB
W.R. Mccullin
Physical Medicine · 36d
Cleared Aug 31, 1982
NIC OPTRONICS CS-2000
K822215 · HOX
Nicolet Biomedical Instruments
Ophthalmic · 36d
Cleared Aug 31, 1982
CHIROPRACTIC ADJUSTING TABLE MODEL 646
K822221 · INQ
Tri W-G, Inc.
Physical Medicine · 36d
Cleared Aug 31, 1982
FRANKLIN QUANTIC 1200
K822236 · DXK
Bruce Franklin, Inc.
Cardiovascular · 34d
Cleared Aug 31, 1982
INDEFLATOR
K822245 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 33d
Cleared Aug 31, 1982
STERILE PROTECTIVE SLEEVE W/TOUGH-BORST
K822290 · DQO
Universal Medical Instrument Corp.
Cardiovascular · 29d