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
161593–161616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1982
ELECTRONIC DIGITAL SPHYGMOMANOMETER
K820300 · DXN
Copal, Inc.
Cardiovascular · 49d
Cleared Mar 25, 1982
FETAL-TEK CONTROL MATURE
K820319 · JJS
Helena Laboratories
Chemistry · 48d
Cleared Mar 25, 1982
LUTEINIZING HORMONE KIT
K820357 · CEP
Pcl-Ria, Inc.
Chemistry · 44d
Cleared Mar 25, 1982
PROFILE GENERAL SET ASSAYED SERUM CONTR
K820468 · DIF
General Diagnostics
Toxicology · 31d
Cleared Mar 25, 1982
RELIEF VALVE-HONAN INTRAOC. PRESSURE
K820526 · LCC
The Lebanon Corp.
Ophthalmic · 27d
Cleared Mar 25, 1982
DECUBICARE PADS & ACCESSORIES
K820584 · FMP
Abco Dealers, Inc.
General Hospital · 21d
Cleared Mar 25, 1982
DISPERSED PHASE ALLOY
K820617 · EJJ
Goldsmith & Revere, Inc.
Dental · 17d
Cleared Mar 25, 1982
CORNING 902 SODIUM POTASSIUM ANALYZER
K820629 · CFM
Corning Medical & Scientific
Chemistry · 17d
Cleared Mar 25, 1982
COLORIMETRIC URIC ACID REAGENT SET
K820632 · KNK
Biorent Diagnostic, Inc.
Chemistry · 17d
Cleared Mar 25, 1982
CATH-HOLD
K820637 · KOD
Womco Products
Gastroenterology & Urology · 17d
Cleared Mar 25, 1982
ATRAC TM MULTIPURPOSE BALLOON CATHETER
K820646 · DXE
Atrium Medical Corp.
Cardiovascular · 16d
Cleared Mar 25, 1982
OPTICATH
K820674 · DQE
Oximetrix, Inc.
Cardiovascular · 14d
Cleared Mar 25, 1982
TOUCH FLUSH W/Y TRANSDUCER CONNECTOR
K820676 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Mar 25, 1982
TOUCH FLUSH CONTINUOUS FAST/FLUSH
K820677 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Mar 25, 1982
AUTO SECTOR MCU
K827036
Technicare Corp.
Radiology · 87d
Cleared Mar 23, 1982
COMPUDIAL/KP-1
K813107 · LIF
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 140d
Cleared Mar 23, 1982
SORB II
K813574 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 90d
Cleared Mar 23, 1982
CRUCIATE LIGAMENT BUTTON
K813581 · KGS
Biomet, Inc.
General & Plastic Surgery · 85d
Cleared Mar 23, 1982
COBE CENTRY 2000 RX
K820125
Cobe Laboratories, Inc.
Gastroenterology & Urology · 64d
Cleared Mar 23, 1982
UNI-SET
K820128 · BZO
Inhalation Therapy Equipment, Co.
Anesthesiology · 64d
Cleared Mar 23, 1982
DISA WATER CYSTOMETER
K820144 · FAP
Disa Electronics
Gastroenterology & Urology · 63d
Cleared Mar 23, 1982
COBE SINGLE-NEEDLE CONTROLLER #18-756
K820173 · FIF
Cobe Laboratories, Inc.
Gastroenterology & Urology · 61d
Cleared Mar 23, 1982
IMPROVED DYCAL
K820215 · EJK
Dentsply Intl.
Dental · 56d
Cleared Mar 23, 1982
HYDROGEN PEROXIDE TOPICAL
K820221 · LIF
Renal Systems, Inc.
Gastroenterology & Urology · 55d