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

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176,076 results
154489–154512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1984
DISPOSIQUET A DISPOS. TOURNIQUET
K840489 · GAX
Med Lab Products
General & Plastic Surgery · 35d
Cleared Mar 12, 1984
STEIGER TUNNELING INSTRUMENT 285
K840529 · DRC
Evermed, Inc.
Cardiovascular · 33d
Cleared Mar 12, 1984
MOLE-MARKER
K840651 · FTY
Notation Systems, Inc.
General & Plastic Surgery · 26d
Cleared Mar 12, 1984
TRACHEOSTOMY CLEANING TRAY
K840664 · BSY
American Pharmaseal Div. Ahsc
Anesthesiology · 26d
Cleared Mar 12, 1984
CARDIAC CATHETERIZATION PACK
K840671 · DRE
Professional Medical Services
Cardiovascular · 20d
Cleared Mar 12, 1984
SENSIBEAD EIA DIGOXIN KIT
K840673 · KXT
Terumo Medical Corp.
Chemistry · 26d
Cleared Mar 12, 1984
AMYLOID STAIN, CONGO RED HT 60
K840798 · ICH
Sigma Chemical Co.
Pathology · 18d
Cleared Mar 12, 1984
SCAVENGER TUBING 19MM
K840849 · CBN
The Kendal Co.
Anesthesiology · 17d
Cleared Mar 12, 1984
FORMALIN SOLUTION 10% NEUTRAL BUFFER
K840926 · IFP
Sigma Chemical Co.
Pathology · 10d
Cleared Mar 09, 1984
OMEGA 5000
K833978 · DXN
Invivo Research Labs, Inc.
Cardiovascular · 113d
Cleared Mar 09, 1984
AUTOGROUPER 16C SYS AUTOMATED REAG
K834149 · GMQ
Technicon Instruments Corp.
Microbiology · 99d
Cleared Mar 09, 1984
STRATUS THYROID UPTAKE FLUOROMETRIC
K834209 · KHQ
American Dade
Chemistry · 95d
Cleared Mar 09, 1984
AMS GRAM-NEGATIVE IDENT. CARD
K834269 · JTO
Vitek Systems, Inc.
Microbiology · 92d
Cleared Mar 09, 1984
TRI-COUNT 10
K834371 · JPK
Hematology Marketing Assoc.
Hematology · 87d
Cleared Mar 09, 1984
AMS GRAM-POSITIVE IDENT. CARD
K834389 · JTO
Vitek Systems, Inc.
Microbiology · 86d
Cleared Mar 09, 1984
APSARA ANALYZER
K834534 · JJE
Datachem, Inc.
Chemistry · 78d
Cleared Mar 09, 1984
LEECO E2 QUANT DIAG. TEST KIT
K834586 · CHP
Leeco Diagnostics, Inc.
Chemistry · 71d
Cleared Mar 09, 1984
AVL MODEL 945 BLOOD GAS SYSTEM
K834601 · CHL
Avl Scientific Corp.
Chemistry · 70d
Cleared Mar 09, 1984
SDI PREPAX DILUKIT 29-1000
K840044 · JJO
Scientific Distributors, Inc.
Toxicology · 63d
Cleared Mar 09, 1984
ORION BIOFEEDBACK DATA ACQUISITION
K840223 · HCC
Self Regulation Systems, Inc.
Neurology · 50d
Cleared Mar 09, 1984
ALLERCOAT MULTISCREEN DISCS
K840360 · DHB
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Mar 09, 1984
DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO
K840404 · DAD
Tago, Inc.
Immunology · 38d
Cleared Mar 09, 1984
ACID FAST BACILLI STAIN CONTROL
K840515 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 32d
Cleared Mar 09, 1984
METACHROMATIC GRANULE STAIN CONTROL
K840516 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 32d