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
138649–138672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1987
BIOTROL ALT/TGP MONOREACTIF
K872830 · CKA
Biotrol, USA, Inc.
Chemistry · 27d
Cleared Aug 13, 1987
CALCITONIN RIA KIT
K872880 · JKR
Endocrine Associates, Inc.
Chemistry · 23d
Cleared Aug 13, 1987
CARBON DIOXIDE
K872886 · KMS
Catachem, Inc.
Chemistry · 22d
Cleared Aug 13, 1987
LIGHTPLAST(TM)
K872975 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 14d
Cleared Aug 12, 1987
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · LIT
Cook, Inc.
Cardiovascular · 204d
Cleared Aug 12, 1987
PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K871080 · DQY
Catheter Technology Corp.
Cardiovascular · 147d
Cleared Aug 12, 1987
OLYMPUS ANGIOSCOPY PUMP
K871422 · DQI
Olympus Corp.
General Hospital · 125d
Cleared Aug 12, 1987
THE TELESCAN C.A.R.E. SYSTEM
K871587 · DSH
Telescan Medical Systems
Cardiovascular · 110d
Cleared Aug 12, 1987
OSTO-PURE
K871738 · EXB
Clearchem Corp.
Gastroenterology & Urology · 99d
Cleared Aug 12, 1987
CT9800 QUICK 3D #B7919DA
K871859 · JAK
General Electric Co.
Radiology · 91d
Cleared Aug 12, 1987
KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE
K871984 · LMD
Eastman Kodak Company
Radiology · 82d
Cleared Aug 12, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871992 · DXY
Telectronics, Inc.
Cardiovascular · 78d
Cleared Aug 12, 1987
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
K871994 · LLL
Behring Diagnostics, Inc.
Immunology · 78d
Cleared Aug 12, 1987
K AND D HOME TRACT
K872121 · HST
Joseph A. Kott, M.D.
Neurology · 77d
Cleared Aug 12, 1987
I.S.G. 3DMV WORKSTATION
K872150 · JAK
I.S.G. Technologies, Inc.
Radiology · 69d
Cleared Aug 12, 1987
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · DWF
Shiley, Inc.
Cardiovascular · 69d
Cleared Aug 12, 1987
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161 · DTL
Shiley, Inc.
Cardiovascular · 69d
Cleared Aug 12, 1987
DOUBLE LUMEN CATHETER
K872248 · DQO
Cordis Corp.
Cardiovascular · 61d
Cleared Aug 12, 1987
DS-7 NUCLEAR MEDICINE GAMMA CAMERA
K872297 · IYX
Sopha Medical Systems, Inc.
Radiology · 57d
Cleared Aug 12, 1987
BC 1400 HAND POSITIONER
K872316 · KPR
Instrumentation Industries, Inc.
Radiology · 56d
Cleared Aug 12, 1987
BC 1800 FINGER POSITIONER
K872317 · KPR
Instrumentation Industries, Inc.
Radiology · 56d
Cleared Aug 12, 1987
GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT
K872325 · JTW
Technology Management & Marketing, Inc.
Microbiology · 56d
Cleared Aug 12, 1987
POWER-AID INDEPENDENT X-RAY POWER SOURCE
K872445 · IZO
Advanced Instrument Development, Inc.
Radiology · 50d
Cleared Aug 12, 1987
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
K872485 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 51d