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
163681–163704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1981
EAGLE I HEARING AID
K811988 · ESD
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jul 28, 1981
STAPH-IDENT
K811998 · JTO
Analytical Products, Inc.
Microbiology · 14d
Cleared Jul 28, 1981
GASTRIN RIA DIAGNOSTIC KIT
K812004 · CGC
Abbott Laboratories
Chemistry · 14d
Cleared Jul 28, 1981
CORDIOTOMY RESERVOIR
K812008 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Jul 28, 1981
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500
K812009 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Jul 28, 1981
KOI LACRIMAL INTUBATION SYSTEM
K812010 · HMX
Koi, Inc.
Ophthalmic · 11d
Cleared Jul 28, 1981
BLADE GAUGE
K812011 · HOE
Koi, Inc.
Ophthalmic · 11d
Cleared Jul 28, 1981
FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
K812013 · GTX
Springwood Microbiologicals
Microbiology · 11d
Cleared Jul 28, 1981
MONOJECT STERILE M506 6CC SYRINGES
K812023 · FMF
Sherwood Medical Co.
General Hospital · 8d
Cleared Jul 28, 1981
IMED ACCUSET CASSETTE
K812035 · FRN
Imed Corp.
General Hospital · 8d
Cleared Jul 28, 1981
TEMPERATURE MONITOR 130/131/133
K812037 · FLL
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 7d
Cleared Jul 27, 1981
SEMI-CONSTRAINT KEE JOINT HINGE PROSTH
K811105 · KRO
Allo Pro Corp.
Orthopedic · 95d
Cleared Jul 27, 1981
CHEMSTRIP L
K811189 · GHD
Biodynamics Corp.
Hematology · 89d
Cleared Jul 27, 1981
ARACHIDONIC ACID
K811290 · JBX
Bio/Data Corp.
Chemistry · 77d
Cleared Jul 27, 1981
COMMAND P5(UNIPOLAR PULSE GENERATOR)
K811401
Cardiac Pacemakers, Inc.
Cardiovascular · 69d
Cleared Jul 27, 1981
COMMAND P5(BIPOLAR PULSE GENERATOR)
K811402 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 70d
Cleared Jul 27, 1981
CUSTOM IN-THE-EAR HEARING AID
K811719 · ESD
Hearing Health Group, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 27, 1981
ACCRA-LAB GRAM STAIN SET 55760
K811780 · JTS
Accra Laboratories, Inc.
Pathology · 34d
Cleared Jul 27, 1981
SIGMA PROCEDURE #890
K811784 · GJS
Sigma Chemical Co.
Toxicology · 34d
Cleared Jul 27, 1981
PO-200 BLOOD OXYGEN MONITOR
K811836 · KLK
Sumitomo Electric Industries, Inc.
Anesthesiology · 27d
Cleared Jul 27, 1981
SKIN STAPLE EXTRACTOR
K811887 · KBC
Sierra Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Jul 27, 1981
ORTHO SICKLE CELL CONTROLS
K811894 · GKA
Ortho Diagnostic Systems, Inc.
Hematology · 26d
Cleared Jul 27, 1981
NEOCEPT
K811941 · JHJ
Organon, Inc.
Chemistry · 21d
Cleared Jul 27, 1981
COMBO-FER IRON DIAGNOSTIC
K811954 · JQG
Immuno Assay Corp.
Chemistry · 19d