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
160345–160368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1982
MCPARLAND SCALP VEIN CATHETER
K821001 · LFJ
Renal Systems, Inc.
Gastroenterology & Urology · 105d
Cleared Jul 22, 1982
RIA-QUANT FPA TEST KIT
K821151 · DAN
Mallinckrodt Critical Care
Immunology · 87d
Cleared Jul 22, 1982
GLUCOSE(ENZYMATIC) REAGENT SET
K821204 · CGA
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
SGPT-UV REAGENT SET
K821206 · CKA
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
UREA NITROGEN REAGENT SET
K821212 · CDW
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
C-REACTIVE PROTEIN CONTROL
K821412 · DCK
Syva Co.
Chemistry · 71d
Cleared Jul 22, 1982
P6S ATHLETIC
K821449 · IPF
Squire, Sanders & Dempsey
Physical Medicine · 69d
Cleared Jul 22, 1982
PROFLEX
K821672 · HRX
Utah Medical Products, Inc.
Orthopedic · 43d
Cleared Jul 22, 1982
ARTHROLUX ARTHROSCOPE
K821694 · HRX
Arthro-Tech, Inc.
Orthopedic · 44d
Cleared Jul 22, 1982
RAPIDO-LASTIC IN STERILE FORM
K821701 · EFQ
Conco Medical Co.
General & Plastic Surgery · 44d
Cleared Jul 22, 1982
MI DAS 1000 AUTOMATIC SLIDE STAINER
K821830 · KPA
Innovative Medical Systems, Inc.
Hematology · 30d
Cleared Jul 22, 1982
I.M. ARTHROSCOPE
K821847 · HRX
Instrument Makar, Inc.
Orthopedic · 30d
Cleared Jul 22, 1982
U-100 BAG
K821853 · KNX
Medical Technologies of Georgia
Gastroenterology & Urology · 29d
Cleared Jul 22, 1982
U-200 BAG
K821854 · KNX
Medical Technologies of Georgia
Gastroenterology & Urology · 29d
Cleared Jul 22, 1982
NEIDENT*
K821907 · JTO
Analytical Products, Inc.
Microbiology · 24d
Cleared Jul 22, 1982
ZETA-CORT
K821931 · CGR
Amf Biological and Diagnostics Co.
Chemistry · 23d
Cleared Jul 22, 1982
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT
K821944 · JHI
Hybritech, Inc.
Chemistry · 23d
Cleared Jul 22, 1982
96 WELL DISPENSER
K821961 · JTC
Skatron, Inc.
Microbiology · 21d
Cleared Jul 22, 1982
125I QUICK-MB TEST KIT FOR QUANTITATION
K821964 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 21d
Cleared Jul 22, 1982
GRAMSTAIN SET
K821977 · HYI
Granite Diagnostics, Inc.
Pathology · 16d
Cleared Jul 22, 1982
TITAN GEL CPK/LDH ISOENZYME CONTROL
K821981 · JJT
Helena Laboratories
Chemistry · 16d
Cleared Jul 22, 1982
QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
K821984 · DCK
Kallestad Laboratories, Inc.
Immunology · 16d
Cleared Jul 22, 1982
BACILLU S SUBTILIS BIOLOGICAL INDICA.
K822024 · FRC
Findley Research, Inc.
General Hospital · 13d
Cleared Jul 22, 1982
H-H NERVE ROOT RETRACTOR
K822048 · HAO
Holter-Hausner Intl.
Neurology · 10d