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
164713–164736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1981
PREHEPARINZED SYRINGE
K803302 · FMF
The University of Chicago
General Hospital · 99d
Cleared Apr 08, 1981
DENTAL CHEWING GUM (SUGARLESS)
K810037 · EJR
Mcdennan Oral Products, Inc.
Dental · 89d
Cleared Apr 08, 1981
BIO CONDYLAR TM KNEE
K810328 · JWH
Depuy, Inc.
Orthopedic · 58d
Cleared Apr 08, 1981
DEPUY SEGMENTALSPINAL SYSTEM
K810329 · KWP
Depuy, Inc.
Orthopedic · 58d
Cleared Apr 08, 1981
ANIMAL SERUM PRODUCTS
K810478 · KIS
Animal Health Laboratories, Inc.
Toxicology · 44d
Cleared Apr 08, 1981
SCRIPPSYSTEM C3 RID KIT
K810501 · CZW
Scripps-Miles, Inc.
Immunology · 43d
Cleared Apr 08, 1981
SCRIPPSYSTEM C4 RID KIT
K810502 · DBI
Scripps-Miles, Inc.
Immunology · 43d
Cleared Apr 08, 1981
THERMAL PRINTER PAPER
K810549 · JJE
Nobel Scientific Industries, Inc.
Chemistry · 37d
Cleared Apr 08, 1981
SILVER ANODE
K810550 · JFS
Nobel Scientific Industries, Inc.
Chemistry · 37d
Cleared Apr 08, 1981
ATRIAL-VENTRICULAR PACING ELECTRODE KIT
K810642 · LDF
Stanco Medical, Inc.
Cardiovascular · 29d
Cleared Apr 08, 1981
UNIVERSAL PACING ELECTRODE KIT
K810643 · LDF
Stanco Medical, Inc.
Cardiovascular · 29d
Cleared Apr 08, 1981
TEMPTRON #'S 6804/6805
K810657 · LDF
Medtronic Vascular
Cardiovascular · 28d
Cleared Apr 08, 1981
HEMOCOLOR STAIN SET
K810684 · ICC
Harleco
Microbiology · 26d
Cleared Apr 08, 1981
I.V. ADMINISTRATION SET
K810757 · FDA
American Mcgaw
Gastroenterology & Urology · 19d
Cleared Apr 08, 1981
KEY-MED FIBRESCOPE DISINFECTION TROLLEY
K810818 · FEB
Keymed, Inc.
General Hospital · 15d
Cleared Apr 08, 1981
ACRODISC
K810829 · JRL
Gelman Sciences, Inc.
Chemistry · 14d
Cleared Apr 08, 1981
SORVALL RT6000 REFRIGERATED TABLETOP
K810833 · JQC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 14d
Cleared Apr 08, 1981
FOLLICLE STIMULATING HORMONE ANTISERUM
K810852 · CGJ
Pcl-Ria, Inc.
Chemistry · 9d
Cleared Apr 08, 1981
T3 UPTAKE KIT
K810857 · KHQ
Immuno Assay Corp.
Chemistry · 9d
Cleared Apr 08, 1981
CRP SLIDE
K810862 · DCN
Syn-Kit, Inc.
Immunology · 8d
Cleared Apr 07, 1981
P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH
K810060 · HRY
Howmedica Corp.
Orthopedic · 84d
Cleared Apr 07, 1981
TRAY, CATHERIZATION, URETHRAL
K810249 · KOD
Megaplast, Inc.
Gastroenterology & Urology · 68d
Cleared Apr 07, 1981
TRAY, IRRIGATION
K810250 · KNT
Megaplast, Inc.
Gastroenterology & Urology · 68d
Cleared Apr 07, 1981
PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT
K810506 · OCX
Propper Mfg. Co., Inc.
Gastroenterology & Urology · 42d