FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
160561–160584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 14, 1982
MIC-2000 PLUS, 96 CHANNEL DISPENSER
K820821 · JTC
Dynatech Corp.
Microbiology · 21d
Cleared Apr 14, 1982
SAMM
K820828 · DXH
Dart Medical Equipment
Cardiovascular · 19d
Cleared Apr 14, 1982
PERCOR PERCUTANEOUS INTRODUCER
K820834 · DYB
Datascope Corp.
Cardiovascular · 19d
Cleared Apr 14, 1982
CURITY SHETHOSCOPE SECURING PADS
K820872 · KGX
The Kendal Co.
General & Plastic Surgery · 16d
Cleared Apr 14, 1982
DISPOSABLE SURGICAL FACE MASK
K820893 · FXX
Anago, Inc.
General Hospital · 15d
Cleared Apr 13, 1982
PERCUTANEOUS NEPHROSTOMY SET
K820867 · GBO
Van-Tec, Inc.
General & Plastic Surgery · 15d