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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83545–83568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1999
DIGITEC TWO STAGE COMPRESSION KIT
K993681 · IZH
Digitec Medical Service Corp.
Radiology · 50d
Cleared Dec 21, 1999
UROVIEW 2800
K993687 · OWB
Ge Dec Medical Systems
Radiology · 50d
Cleared Dec 21, 1999
MODIFICATION OF PARAPOST CEMENT
K993710 · EMA
Coltene/Whaledent, Inc.
Dental · 48d
Cleared Dec 21, 1999
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
K993716 · EBF
Harry J. Bosworth Co.
Dental · 49d
Cleared Dec 21, 1999
BINDAZYME ANTI-DSDNA EIA KIT
K993727 · LRM
The Binding Site, Ltd.
Immunology · 57d
Cleared Dec 21, 1999
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755 · DKB
Syva Co.
Toxicology · 46d
Cleared Dec 21, 1999
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA,...
K993796 · LDJ
American Bio Medica Corp.
Toxicology · 42d
Cleared Dec 21, 1999
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL...
K993812 · JSM
Hardy Diagnostics
Microbiology · 41d
Cleared Dec 21, 1999
THE SOUNDVASER DISSECTION SYSTEM
K993868 · LFL
Sound Surgical Technologies, LLC
General & Plastic Surgery · 36d
Cleared Dec 21, 1999
M-PACT CORNEAL LIGHT SHIELD
K993883 · HOZ
M-Pact Corp.
Ophthalmic · 36d
Cleared Dec 21, 1999
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES,...
K993935 · LPL
Wesley Jessen Corp.
Ophthalmic · 32d
Cleared Dec 21, 1999
KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY
K993947 · IZI
Siemens Corp.
Radiology · 29d
Cleared Dec 21, 1999
PENSIL TRAUMA, MODEL WWS6100
K993962 · KPR
Wuestec Medical, Inc.
Radiology · 57d
Cleared Dec 21, 1999
HARDYDISK AZITHROMYCIN 15MCG
K993994 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Dec 21, 1999
CG-2100 ECG TRANSMITTER
K994009 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 25d
Cleared Dec 21, 1999
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
K994045 · LCP
Primus Corp.
Hematology · 22d
Cleared Dec 21, 1999
E. HISTOLYTICA II
K994101 · KHW
Techlab, Inc.
Microbiology · 15d
Cleared Dec 21, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K994110 · DFC
Diasorin/American Standard Companies
Chemistry · 15d
Cleared Dec 21, 1999
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
K994175 · HBB
Sodemsystems
Neurology · 11d
Cleared Dec 21, 1999
SYNTHES CERVIFIX SYSTEM
K994187 · KWP
Synthes (Usa)
Orthopedic · 8d
Cleared Dec 20, 1999
C3 MININEPH ANTISERUM
K981783 · CZW
The Binding Site, Ltd.
Immunology · 579d
Cleared Dec 20, 1999
C4 MININEPH ANTISERUM
K981785 · DBI
The Binding Site, Ltd.
Immunology · 579d
Cleared Dec 20, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
K981915 · JJY
The Binding Site, Ltd.
Immunology · 567d
Cleared Dec 20, 1999
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
K982100 · CFN
The Binding Site, Ltd.
Immunology · 553d