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
154969–154992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1984
VITAL SIGNS MONITOR 3
K833584 · DPS
Physio-Control Corp.
Cardiovascular · 110d
Cleared Jan 30, 1984
TLS BULB DRAINAGE SYSTEM
K833586 · GCY
Porex Medical
General & Plastic Surgery · 110d
Cleared Jan 30, 1984
CERTAIN MANUAL SURG. INSTRU. ACCESS
K833629 · HTD
Cimed Intl., Inc.
General & Plastic Surgery · 108d
Cleared Jan 30, 1984
ACA THYROXINE UPTAKE ANALYTICAL TEST
K833703 · KHQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 104d
Cleared Jan 30, 1984
BTC URINE LH ASSAY
K833710 · CED
Btc Diagnostics, Inc.
Chemistry · 102d
Cleared Jan 30, 1984
MODEL 2000 AMBULATORY MED. INFUSER
K833723 · FRN
Parker Hannifin Corp.
General Hospital · 98d
Cleared Jan 30, 1984
AC ADAPTERS FOR BLOOD PRESSURE METERS
K833753 · DXN
Philips Park
Cardiovascular · 83d
Cleared Jan 30, 1984
ELECTRONIC DIGITAL FEVER THERMOMETER
K833755 · FLL
North American Philips Corp.
General Hospital · 96d
Cleared Jan 30, 1984
ANGIOTENSIN CONVERTING ENZYME
K833777 · CIB
Immuno-Diagnostic Laboratories
Chemistry · 95d
Cleared Jan 30, 1984
CHEM KIT PHENOBARBITAL
K833796 · DLZ
Abbott Laboratories
Toxicology · 90d
Cleared Jan 30, 1984
CHEMKIT PHENYTOIN DIAG. KIT
K833806 · DIP
Abbott Laboratories
Toxicology · 90d
Cleared Jan 30, 1984
ACTH RIA
K833849 · CKG
Syncor Intl. Corp.
Chemistry · 87d
Cleared Jan 30, 1984
COATEST ANTIPLASMIN
K833890 · LGP
Kabivitrum, Inc.
Hematology · 82d
Cleared Jan 30, 1984
COATEST HEPARIN
K833891 · KFF
Kabivitrum, Inc.
Hematology · 82d
Cleared Jan 30, 1984
COATEST FACTOR VIII
K833892 · GGP
Kabivitrum, Inc.
Hematology · 82d
Cleared Jan 30, 1984
INFUSION PORT BALLOON THERMODILUTION
K833918 · DYG
Critikon Company, LLC
Cardiovascular · 77d
Cleared Jan 30, 1984
CENTRICON MICRO-CONCENTRATOR
K833919 · JJH
Amicon, Inc.
Chemistry · 77d
Cleared Jan 30, 1984
ACETONE ALCOHOL SWABS
K833936 · LKB
Concord Laboratories, Inc.
General Hospital · 76d
Cleared Jan 30, 1984
PEGASUS MATTRESS
K833964 · FNM
Dermalex Co.
General Hospital · 75d
Cleared Jan 30, 1984
QUICK-COUNT
K833971 · GKL
Seragen Diagnostics, Inc.
Hematology · 75d
Cleared Jan 30, 1984
VENTREZYME THEOPHYLLINE IMMUNOASSAY
K833989 · KLS
Vxr, Inc.
Immunology · 73d
Cleared Jan 30, 1984
BIPOLAR HIP DEVICE
K833991 · KWY
Zimmer
Orthopedic · 70d
Cleared Jan 30, 1984
ALCOHOL SWABS
K833993 · LKB
Concord Laboratories, Inc.
General Hospital · 70d
Cleared Jan 30, 1984
QCA CHEMISTRY ANALYZER
K833998 · JJF
Bd Becton Dickinson Vacutainer...
Chemistry · 70d