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
142249–142272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1986
NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
K863438 · JJP
Nova Biomedical Corp.
Chemistry · 24d
Cleared Sep 29, 1986
STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II
K863447 · GET
Stryker Corp.
General & Plastic Surgery · 21d
Cleared Sep 29, 1986
POTASSIUM TEST
K863486 · CEJ
Sclavo, Inc.
Chemistry · 20d
Cleared Sep 29, 1986
PARAMAX ELECTROLYTE CALIBRATOR
K863489 · JIX
American Dade
Chemistry · 20d
Cleared Sep 29, 1986
BICONDYLAR TOE PROSTHESIS
K863528
Depuy, Inc.
Orthopedic · 19d
Cleared Sep 29, 1986
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 29, 1986
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
K863560 · GBS
Uresil Corp.
General & Plastic Surgery · 17d
Cleared Sep 29, 1986
URESIL 150CC BELLOWS RESERVOIR
K863562 · GCY
Uresil Corp.
General & Plastic Surgery · 17d
Cleared Sep 29, 1986
LE VEEN WOUND SPLINT
K863570 · KGS
Tek-Aid, Inc.
General & Plastic Surgery · 17d
Cleared Sep 29, 1986
AMYLASE PROCEDURE
K863588 · JFJ
Data Medical Associates, Inc.
Chemistry · 14d
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