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

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176,076 results
161953–161976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K820263 · CHH
Eastman Kodak Company
Chemistry · 16d
Cleared Feb 18, 1982
RAICHEM GOT (AST) REAGENT
K820270 · CIT
Reagents Applications, Inc.
Chemistry · 16d
Cleared Feb 18, 1982
4050/4051 ULTRASPEC
K820273 · JJQ
Lkb Instruments, Inc.
Chemistry · 16d
Cleared Feb 18, 1982
INTRAVASCULAR ADMINISTRATION SET
K820278 · FPA
Y
General Hospital · 16d
Cleared Feb 18, 1982
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285 · LCQ
Syva Co.
Toxicology · 16d
Cleared Feb 18, 1982
SIEMENS SIRESKOP 4
K827065
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Feb 18, 1982
PODIOSCOPE BY ARROW
K827069
Arrow X-Ray Corp.
Radiology · 31d
Cleared Feb 15, 1982
TRACE ANALYTICAL REDUCTION GAS ANALYZ
K820025 · KZQ
Trace Analytical
Toxicology · 41d
Cleared Feb 12, 1982
ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER
K813170 · GAG
Surgeons Choice, Inc.
General & Plastic Surgery · 87d
Cleared Feb 12, 1982
MEDICAL MULTILITH PULSE GENERA-1140
K813246 · DXY
Ela Medical, Inc.
Cardiovascular · 86d
Cleared Feb 12, 1982
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR
K813350 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 77d
Cleared Feb 12, 1982
FETASCAN 2000,2000A OBSTETRICAL DATA
K813457 · HGM
Cranbury Medical Labs, Inc.
Obstetrics & Gynecology · 64d
Cleared Feb 12, 1982
SIL-V-UR CHEST CATHETER
K813463 · GBS
C.R. Bard, Inc.
General & Plastic Surgery · 63d
Cleared Feb 12, 1982
CURITY BEDSIDE DRAINAGE BAG
K813621 · KNX
The Kendal Co.
Gastroenterology & Urology · 45d
Cleared Feb 12, 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 32d
Cleared Feb 12, 1982
GLYCO-SEP REAGENT TEST SET
K820076 · LCP
Clin Tech Diagnostics Corp.
Hematology · 31d
Cleared Feb 12, 1982
X-RAY GUAZE SPONGES
K820106 · EFQ
Stan-Pak Ent.
General & Plastic Surgery · 28d
Cleared Feb 12, 1982
GUAZE SPONGES, PLAIN
K820107 · EFQ
Stan-Pak Ent.
General & Plastic Surgery · 28d
Cleared Feb 12, 1982
TOPPER SPONGES
K820108 · NAB
Stan-Pak Ent.
General & Plastic Surgery · 28d
Cleared Feb 12, 1982
BIOX III
K820110 · DQA
Biox Technology, Inc.
Anesthesiology · 28d
Cleared Feb 12, 1982
SYSTEM V.HEART RATE/RESPIR. RATE MONIT.
K820114 · DRT
Narco Air-Shields
Cardiovascular · 28d
Cleared Feb 12, 1982
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121 · DTB
Telectronics, Inc.
Cardiovascular · 25d
Cleared Feb 12, 1982
WEBRIL CAST PADDING
K820140 · ITG
Stan-Pak Ent.
Physical Medicine · 24d
Cleared Feb 12, 1982
SPECIALIST CAST PADDING
K820155 · ITG
Stan-Pak Ent.
Physical Medicine · 24d