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
81985–82008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2000
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
K002030 · MWI
Invivo Research, Inc.
Cardiovascular · 85d
Cleared Sep 26, 2000
FREEZER TEETHER
K002066 · KKO
Cool Baby, Inc.
Dental · 81d
Cleared Sep 26, 2000
ATAC PAK ALP REAGENT KIT
K002285 · CJE
Elan Diagnostics
Chemistry · 62d
Cleared Sep 26, 2000
SUPER 6
K002300 · EJH
Dental Alloy Products, Inc.
Dental · 60d
Cleared Sep 26, 2000
SUPER 14
K002302 · EJH
Dental Alloy Products, Inc.
Dental · 60d
Cleared Sep 26, 2000
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · KHS
Diagnostic Chemicals , Ltd.
Toxicology · 55d
Cleared Sep 26, 2000
CLOUD CUFF
K002360 · DXQ
Parts Port, Ltd.
Cardiovascular · 54d
Cleared Sep 26, 2000
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
K002461 · EMA
Shofu Dental Corp.
Dental · 47d
Cleared Sep 26, 2000
PROTEIN C REAGENT
K002541 · GGP
Dade Behring, Inc.
Hematology · 41d
Cleared Sep 26, 2000
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL...
K002770 · LJT
Hdc Corp.
General Hospital · 20d
Cleared Sep 26, 2000
KETAC CEM U
K002793 · EMA
Espe Dental AG
Dental · 19d
Cleared Sep 25, 2000
LIPIDURE REWETTING DROPS
K000975 · MRC
Nof Corp.
Ophthalmic · 182d
Cleared Sep 25, 2000
PERIPHERALLY INSERTED CENTRAL CATHETER
K001874 · LJS
Utah Medical Products, Inc.
General Hospital · 97d
Cleared Sep 25, 2000
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL...
K001958 · MPB
Keystone Medical
Gastroenterology & Urology · 90d
Cleared Sep 25, 2000
ILT 0.014 CATHETER, MODEL C114NL2
K001992 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 88d
Cleared Sep 25, 2000
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414 · LBI
Fisher &Paykel Healthcare , Ltd.
General Hospital · 49d
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
K002865 · JJS
Bio-Rad
Chemistry · 12d
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
K002866 · JJS
Bio-Rad
Chemistry · 12d
Cleared Sep 22, 2000
FREEDOM, MODEL 4660
K001023 · SEJ
Johnson & Johnson Consumer Companies,...
General & Plastic Surgery · 176d
Cleared Sep 22, 2000
VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD...
K001926 · DYB
Thoratec Laboratories Corp.
Cardiovascular · 88d
Cleared Sep 22, 2000
MEDLINE ELECTRONIC POSITIONING CHAIR
K001937 · INO
Medline Industries, Inc.
Physical Medicine · 88d
Cleared Sep 22, 2000
SYNTHES MODULAR FOOT SYSTEM
K001941 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Sep 22, 2000
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
K001945 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Sep 22, 2000
BOLUSPRO ULTRA
K002005 · JAK
Marconi Medical Systems, Inc.
Radiology · 81d