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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
142849–142872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1986
UPDATED STERILE PROCEDURAL KIT
K863632
Biological & Environmental Control...
General & Plastic Surgery · 12d
Cleared Sep 29, 1986
UPDATED STERILE GOWNS, MASKS AND TOWELS
K863637
Biological & Environmental Control...
General & Plastic Surgery · 12d
Cleared Sep 29, 1986
ARTICULAR MOTION DEVICE (AMD4000)
K863639 · BXB
Med Surg Designs, Inc.
Physical Medicine · 12d
Cleared Sep 29, 1986
MEDCOMP DISPOSABLE MANIFOLD SYSTEM
K863661 · DTL
Medical Components, Inc.
Cardiovascular · 11d
Cleared Sep 29, 1986
ARTHROSCOPIC SURGICAL POWER DEVICE
K863696 · KIT
American Edwards Laboratories
Pathology · 7d
Cleared Sep 26, 1986
PROTEX, TAHITI CONDOM
K860680 · HIS
U. C. Import & Co.
Obstetrics & Gynecology · 213d
Cleared Sep 26, 1986
OMNIVAC (VACUUM ELECTRODE SYSTEM)
K861039 · LIH
Physio Technology, Inc.
Neurology · 192d
Cleared Sep 26, 1986
PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
K861929 · BZM
Medical Graphics Corp.
Anesthesiology · 129d
Cleared Sep 26, 1986
THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES
K862224 · JEQ
Xouth, Inc.
Dental · 107d
Cleared Sep 26, 1986
ENZLIPASE, ENZYMATIC LIPASE KIT
K862312 · CHI
Nuclear Diagnostics, Inc.
Chemistry · 100d
Cleared Sep 26, 1986
QMED SELF ADHERING ELECTRODE
K862377 · GXY
Qmed, Inc.
Neurology · 94d
Cleared Sep 26, 1986
SIEGEN HEADPHONES
K862430 · GWJ
Siegen Corp.
Neurology · 92d
Cleared Sep 26, 1986
ALKALINE PHOSPHATASE TEST
K862498 · CJE
King Diagnostics, Inc.
Chemistry · 87d
Cleared Sep 26, 1986
DR-2C (MODIFICATION)
K862596 · DSF
General Devices
Cardiovascular · 91d
Cleared Sep 26, 1986
SENSORMEDICS OXYSHUTTLE(TM)
K862617 · DQA
Sensor Medics Corp.
Anesthesiology · 79d
Cleared Sep 26, 1986
EUROCART SR-4, EUROCART M-IV, ISOCART III
K863010 · EIA
Sds Dental, Inc.
Dental · 49d
Cleared Sep 26, 1986
BILIRUBIN TOTAL DIRECT
K863057 · CIG
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
CALCIOMETER
K863059 · CIA
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
TRIGLYCERIDES-E
K863075 · CDT
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
ACE II (TRI-LEVEL)
K863095 · JIX
Medical Analysis Systems, Inc.
Chemistry · 44d
Cleared Sep 26, 1986
URIC ACID PROCEDURE
K863251 · KNK
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K863254 · CDT
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
CALCIUM PROCEDURE
K863256 · CIC
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
AST/GOT PROCEDURE
K863257 · CIT
Data Medical Associates, Inc.
Chemistry · 32d