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
160609–160632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1982
OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.
K821376 · CBK
Ohio Medical Products
Anesthesiology · 50d
Cleared Jun 29, 1982
OPHTHALMIC EYEWEAR
K821391 · HQZ
Nordic Eyewear, Inc.
Ophthalmic · 49d
Cleared Jun 29, 1982
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
K821650 · CAD
Draeger Medical, Inc.
Anesthesiology · 25d
Cleared Jun 29, 1982
DISPOSABLE INTRAVENOUS INJECTION SYSTEM
K821764 · FPA
Medical Systems Research
General Hospital · 20d
Cleared Jun 28, 1982
IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM
K827370
Irex Corp.
Radiology · 77d
Cleared Jun 25, 1982
MEDILAC #SR4 & SR 40
K820256 · DSH
Spelna, Inc.
Cardiovascular · 147d
Cleared Jun 25, 1982
QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL
K820630 · JPC
Isolab, Inc.
Hematology · 109d
Cleared Jun 25, 1982
AIRWAYS
K820709 · CAE
Seven Harvest Intl. Import & Export
Anesthesiology · 99d
Cleared Jun 25, 1982
P105
K820827
Eurotan Intl.
Physical Medicine · 91d
Cleared Jun 25, 1982
AUTOMATIC OBJECTIVE REFRACTOR 2000
K820877 · HKO
Dicon, Inc.
Ophthalmic · 87d
Cleared Jun 25, 1982
SKIN MARKERS
K821063 · FZZ
Devon Industries, Inc.
General & Plastic Surgery · 110d
Cleared Jun 25, 1982
PENETRAK TM
K821186 · GKZ
Syva Co.
Hematology · 59d
Cleared Jun 25, 1982
CORNING CPF 550 LENS
K821398 · HQG
Corning Medical & Scientific
Ophthalmic · 45d
Cleared Jun 25, 1982
ARTERIAL BLOOD SAMPLING KIT
K821406 · CBT
Dhd Medical Products Div. Diemolding...
Anesthesiology · 45d
Cleared Jun 25, 1982
HISTOSET IMMUNOPEROFIDASE TISSUE
K821411 · GQL
Immulok, Inc.
Pathology · 44d
Cleared Jun 25, 1982
ULTRACHEM E-GLU #64976&65040
K821475 · CFR
Emd Chemicals, Inc.
Chemistry · 38d
Cleared Jun 25, 1982
CENTRAL DISPLAY SYSTEM #CS400
K821479 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 38d
Cleared Jun 25, 1982
ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT
K821553 · KHQ
Amf Biological and Diagnostics Co.
Chemistry · 31d
Cleared Jun 25, 1982
ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT
K821554 · CDX
Amf Biological and Diagnostics Co.
Chemistry · 31d
Cleared Jun 25, 1982
IMMULOK CULTURESET
K821567 · GQL
Immulok, Inc.
Microbiology · 31d
Cleared Jun 25, 1982
FETAL MONITOR #FM 750
K821580 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 31d
Cleared Jun 25, 1982
ERIKA HPF 50 DIALYZER
K821587 · FJI
Erika, Inc.
Gastroenterology & Urology · 24d
Cleared Jun 25, 1982
HEMOGLOBIN REAGENT
K821658 · KHG
Anco Medical Reagents & Assoc.
Hematology · 21d
Cleared Jun 25, 1982
BIO-CHECK GRAM STAIN CONTROL
K821660 · JTR
American Scientific Products
Microbiology · 21d