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
161401–161424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1982
MARK III OXYGEN WALKER SYSTEM
K820836 · BYJ
Union Carbide Corp.
Anesthesiology · 20d
Cleared Apr 15, 1982
MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY
K820852 · HSB
Serrano Intl.
Orthopedic · 20d
Cleared Apr 15, 1982
NORTON MANIFOLD
K820864 · DTL
Norton Performance Plastics Corp.
Cardiovascular · 17d
Cleared Apr 15, 1982
MARQUETTE OPTION II ECG ANALYSIS COMPUT
K820885 · LOS
Marquette Electronics, Inc.
Cardiovascular · 16d
Cleared Apr 15, 1982
COLD ROLL
K820901 · IME
North Bank Labs, Inc.
Physical Medicine · 15d
Cleared Apr 15, 1982
PBC NEEDLE BY NIPRO MED. INDUSTRIES
K820911 · FMI
Philadelphia Biologics Center
General Hospital · 14d
Cleared Apr 15, 1982
SYSTEM 287 SCANNER
K827209
Diagnostic Sonar USA
Radiology · 45d
Cleared Apr 14, 1982
COLORLESS DISPOSIBLE PLASTIC SYRINGES
K813157 · FMF
Sam Joo Industrial Co., Ltd.
General Hospital · 159d
Cleared Apr 14, 1982
LECTIN-A
K820368 · KSI
American Dade
Hematology · 64d
Cleared Apr 14, 1982
HISTOSET IMMUNOPEROXIDASE TISSURE KIT
K820390 · LKH
Immulok, Inc.
Chemistry · 63d
Cleared Apr 14, 1982
ALPHA PLASMA TRANSFER SET
K820447 · KSB
Alpha Therapeutic Corp.
Hematology · 55d
Cleared Apr 14, 1982
ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
K820531 · LHT
Meridian Diagnostics, Inc.
Microbiology · 43d
Cleared Apr 14, 1982
TREP CARD EIKEN
K820567 · GMQ
Syn-Kit, Inc.
Microbiology · 43d
Cleared Apr 14, 1982
FLEX-E1 ECG ELECTRODE
K820579 · DRS
Conmedcorp
Cardiovascular · 42d
Cleared Apr 14, 1982
SICKLE-CHECK
K820642 · GHM
Panmed, Inc.
Hematology · 37d
Cleared Apr 14, 1982
ARROW M.I.S. MULTI-LUMEN CATHETERIZA
K820648 · DQY
Arrow Intl., Inc.
Cardiovascular · 36d
Cleared Apr 14, 1982
SURGICAL INSTRUMENTS
K820682
Intl. Needle, Inc.
General & Plastic Surgery · 34d
Cleared Apr 14, 1982
STAPHYLOCOCCUS LATEX AGGLUTINATION KIT
K820683 · LHT
American Scientific Products
Microbiology · 34d
Cleared Apr 14, 1982
MONOJECT 512 SYRINGES W/WO NEEDLES
K820716 · FMF
Sherwood Medical Co.
General Hospital · 30d
Cleared Apr 14, 1982
ARGYLE THORACIC CATHETERS
K820718 · JOL
Sherwood Medical Co.
General Hospital · 29d
Cleared Apr 14, 1982
FLUOROGEN PAP FIA
K820724 · JFH
Biogenex Laboratories
Chemistry · 28d
Cleared Apr 14, 1982
ACCUSET (R) CASSETTE
K820726 · FRN
Imed Ireland, Ltd.
General Hospital · 28d
Cleared Apr 14, 1982
MR1 LUTROPIN RIA KIT
K820741 · CEP
Microanalytic Research, Inc.
Chemistry · 27d
Cleared Apr 14, 1982
COLORIMETRIC LDH REAGENT SET
K820768 · CFH
Biorent Diagnostic, Inc.
Chemistry · 23d