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
162913–162936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1981
IMMUNOASSAY PLATE
K812860 · JTC
Skatron, Inc.
Microbiology · 13d
Cleared Oct 26, 1981
API GERM TUBE
K812862 · JTO
Analytab Products, Inc.
Microbiology · 13d
Cleared Oct 26, 1981
OPTIONAL TOTAL CA-MODULE FOR IL 504/508
K812872 · CIS
Instrumentation Laboratory CO
Chemistry · 12d
Cleared Oct 26, 1981
PENASE
K812877 · JTO
Analytab Products, Inc.
Chemistry · 12d
Cleared Oct 26, 1981
IMMUNEX CRP
K812881 · DCN
Armkel, LLC
Immunology · 12d
Cleared Oct 26, 1981
RHEUMATEX
K812882 · DHR
Armkel, LLC
Microbiology · 12d
Cleared Oct 23, 1981
NUCLEAR ANTIGENS
K810592 · LLL
Alpha Antigens, Inc.
Immunology · 232d
Cleared Oct 23, 1981
AVI-D CONTROL
K811713 · KSF
Ortho Diagnostic Systems, Inc.
Hematology · 128d
Cleared Oct 23, 1981
PORTABLE OXYGEN GENERATOR
K812282 · CAW
American Marketing Assoc., Inc.
Anesthesiology · 71d
Cleared Oct 23, 1981
AUTOTRANS BT795
K812292 · CAC
Electromedics, Inc.
Anesthesiology · 71d
Cleared Oct 23, 1981
HELENA COLOSCREEN METHOD
K812428 · KHE
Helena Laboratories
Hematology · 59d
Cleared Oct 23, 1981
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
K812455 · DTN
Electromedics, Inc.
Cardiovascular · 56d
Cleared Oct 23, 1981
CELL CULTURE REAGENTS
K812531 · KIT
M.A. Bioproducts
Microbiology · 51d
Cleared Oct 23, 1981
ZEE LIFE SUPPORT AIR PANTS
K812564 · LHX
Zee Medical Products Co., Inc.
Anesthesiology · 45d
Cleared Oct 23, 1981
ELUTION SOLUTION
K812565 · KSG
Biological Corp. of America
Immunology · 44d
Cleared Oct 23, 1981
SPIROMETER FILTER
K812573 · CAH
K & G Healthcare Ind., Inc.
General Hospital · 44d
Cleared Oct 23, 1981
MEDTRONIC #4951
K812599 · DTB
Medtronic Vascular
Cardiovascular · 39d
Cleared Oct 23, 1981
INJECTION CAP, LUER LOCK
K812657 · FPA
Procedure Products, Inc.
General Hospital · 35d
Cleared Oct 23, 1981
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K812667 · BZQ
Honeywell, Inc.
Anesthesiology · 32d
Cleared Oct 23, 1981
FILES & REAMERS
K812692 · EKS
Miltex Instrument Co.
Dental · 31d
Cleared Oct 23, 1981
MODEL 9408 A TELETRACE
K812703 · DXH
Medtronic Vascular
Cardiovascular · 31d
Cleared Oct 23, 1981
STERILE DENTAL ROLL
K812709 · EFN
Medspec Corp.
Dental · 29d
Cleared Oct 23, 1981
SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE
K812730 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 25d
Cleared Oct 23, 1981
RAIN-X
K812737 · BZO
Nova-Ventrx
Anesthesiology · 24d