FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
159769–159792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 25, 1982
DENSCO PROPHY ANGLE
K821686 · EGS
Teledyne Densco
Dental · 17d
Cleared Jun 25, 1982
INJECTION ASPIRATING NEEDLES
K821697 · GAA
American Endoscopy, Inc.
General & Plastic Surgery · 17d
Cleared Jun 25, 1982
NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL
K821706 · EQN
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT
K821707 · EQN
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
NAGASHIMA LIGHT SOURCE UNIT SL-4
K821708 · EQN
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
NAGASHIMA LIGHT SOURCE UNIT SL-5
K821709 · EQN
Kelleher Corp.
Ear, Nose, Throat · 16d