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
162385–162408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1981
KOI DIAMOND KNIFE
K812450 · HNN
Koi, Inc.
Ophthalmic · 24d
Cleared Sep 21, 1981
HIFLO-HP
K812457 · FPB
Tri-Med, Inc.
General Hospital · 21d
Cleared Sep 21, 1981
VARIOUS AURAL GROMMETS
K812460 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 21d
Cleared Sep 21, 1981
MINI O2
K812513 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 19d
Cleared Sep 21, 1981
IMPROVED PLAYTEX TAMPON
K812534 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 18d
Cleared Sep 21, 1981
RELIANCE OPHTHALMIC INSTRUMENT CONTROL
K812544 · HMF
F. & F. Koenigkramer
Ophthalmic · 17d
Cleared Sep 18, 1981
SURFACE REPLACEMENT HIP PROSTHESIS
K811718 · KYB
Biomet, Inc.
Ophthalmic · 92d
Cleared Sep 18, 1981
ULTRASONIC TIPS
K812126 · HQC
CooperVision, Inc.
Ophthalmic · 53d
Cleared Sep 17, 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550 · KKX
3M Company
General Hospital · 441d
Cleared Sep 16, 1981
GLYCOHEMOGLOBIN
K810958 · LCP
Macomb Chemical Co.
Toxicology · 161d
Cleared Sep 16, 1981
CARDIACMONITORS
K811425 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 117d
Cleared Sep 16, 1981
MANUFACTURING PROCESS CHANGE
K811441 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 117d
Cleared Sep 16, 1981
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K811567 · LCP
Ortho Diagnostic Systems, Inc.
Hematology · 104d
Cleared Sep 16, 1981
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
K811671 · GQH
Zeus Scientific, Inc.
Microbiology · 93d
Cleared Sep 16, 1981
GORE-TEX CARDIOVASCULAR PATCH
K811841 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1981
MICROCOIL 150 DIALYZER
K811974 · FHS
Erika, Inc.
Hematology · 65d
Cleared Sep 16, 1981
DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING
K812014 · IYO
Elscint, Inc.
Radiology · 61d
Cleared Sep 16, 1981
MEDTRONIC ENERTRAX MODEL 7100
K812096 · DXY
Medtronic Vascular
Cardiovascular · 54d
Cleared Sep 16, 1981
LKB-BROMMA 2188 ULTROTOME NOVA
K812158 · IDM
Lkb Instruments, Inc.
Hematology · 49d
Cleared Sep 16, 1981
FLUORO AUTOMATIC BRIGHTNESS SYS
K812217 · JAA
Keystone X-Ray, Inc.
Radiology · 42d
Cleared Sep 16, 1981
PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL
K812270 · DTB
Diag Corp.
Cardiovascular · 34d
Cleared Sep 16, 1981
CRYOSAN NORMAL SALINE
K812309 · GIF
Cryosan, Inc.
Chemistry · 30d
Cleared Sep 16, 1981
CIRCULATING CYTO-THERMS
K812311 · KZL
Cryosan, Inc.
Hematology · 30d
Cleared Sep 16, 1981
KERMATH L/C ARM
K812332 · KPR
Kermath Mfg. Corp.
Radiology · 29d