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
169825–169848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1979
IMPLANT, H.P. CONDYLAR
K781870 · KWD
Dow Corning Corp. Healthcare...
Orthopedic · 98d
Cleared Feb 09, 1979
SURGICAL EYE SHIELD
K781960 · HJK
Concept, Inc.
Ophthalmic · 80d
Cleared Feb 09, 1979
HVG-100
K790033 · IPF
Elmed, Inc.
Physical Medicine · 37d
Cleared Feb 08, 1979
PRESSURIZER, EXETER CEMENT
K781792 · KIZ
Howmedica Corp.
Pathology · 106d
Cleared Feb 08, 1979
ELECTRODE, MODEL 030-324
K781822 · DTD
Telectronics, Inc.
Cardiovascular · 104d
Cleared Feb 08, 1979
ELECTRODE, MODEL 030-326
K781823 · DTD
Telectronics, Inc.
Cardiovascular · 104d
Cleared Feb 08, 1979
ELECTRODE, MODEL 030-324/4 GUAGE
K781824 · DTD
Telectronics, Inc.
Cardiovascular · 104d
Cleared Feb 08, 1979
RIA KIT, QUANTITOPE IGE
K781904 · DGC
Kallestad Laboratories, Inc.
Immunology · 87d
Cleared Feb 08, 1979
CONTROL STRIP FOR VISUAL URINALYSIS
K781961 · JJW
Miles Laboratories, Inc.
Chemistry · 79d
Cleared Feb 08, 1979
LASER COAGULATOR, MODEL 41AK
K781965 · HQF
Lasertek OY
Ophthalmic · 76d
Cleared Feb 08, 1979
SERACON-A
K782037 · JIX
Bhp Diagnostix, Inc.
Chemistry · 64d
Cleared Feb 08, 1979
SERACON-C
K782038 · JJY
Bhp Diagnostix, Inc.
Chemistry · 64d
Cleared Feb 08, 1979
COAGULATOR, MODEL 40 AARGON
K782106 · HQF
Lasertek OY
Ophthalmic · 57d
Cleared Feb 08, 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149 · DXY
Telectronics, Inc.
Cardiovascular · 44d
Cleared Feb 08, 1979
SERACON-HDL
K782171 · JJX
Bhp Diagnostix, Inc.
Chemistry · 41d
Cleared Feb 08, 1979
BIPOLAR, STANICOR LAMBDA MODEL 236,235
K790014 · DXY
Cordis Corp.
Cardiovascular · 36d
Cleared Feb 08, 1979
SERUM, LACTIC DEHYDROGENASE
K790020 · CFJ
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Feb 08, 1979
ANALYZER, MODEL CC-720
K790026 · GKL
Sysmex Corp.
Hematology · 36d
Cleared Feb 08, 1979
SHAKER, MODEL SH-510
K790027 · JRQ
Sysmex Corp.
Chemistry · 36d
Cleared Feb 08, 1979
FLUID, RHEMOX-HB LYSING
K790030 · GKR
Sysmex Corp.
Hematology · 36d
Cleared Feb 08, 1979
TRACOR, CANNULA, BICEPTS BIPOLAR
K790043 · HIN
Neomed Corp.
Obstetrics & Gynecology · 34d
Cleared Feb 08, 1979
NEEDLE, TRUCARE VACUTAINER
K790086 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 22d
Cleared Feb 08, 1979
ELECTROCARDIOGRAPH, EK-9
K790114 · DPS
Burdick Corp.
Cardiovascular · 17d
Cleared Feb 08, 1979
CARDIOTOMY RESERVOIR CR-2000
K790116 · DTB
Delta Medical Industries
Cardiovascular · 17d