FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84049–84072 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1999
BIO-RAD HOMOCYSTEINE BY HPLC
K993107 · LPS
Bio-Rad
Toxicology · 95d
Cleared Dec 21, 1999
PHILIPS INTURIS DICOM RECORDER
K993227 · LLZ
Philips Medical Systems North...
Radiology · 85d
Cleared Dec 21, 1999
RAPTOR TREATMENT PLANNING SYSTEM
K993359 · IYE
Nomos Corp.
Radiology · 76d
Cleared Dec 21, 1999
TONGUE STABILIZER DEVICE
K993381 · LRK
University of Otago
Dental · 75d
Cleared Dec 21, 1999
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
K993590 · LCP
Pointe Scientific, Inc.,
Chemistry · 60d
Cleared Dec 21, 1999
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
K993612 · MVM
The Binding Site, Ltd.
Immunology · 57d
Cleared Dec 21, 1999
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
K993645 · JAK
Ge Medical Systems, Inc.
Radiology · 54d
Cleared Dec 21, 1999
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
K993655 · GEI
Xomed, Inc.
General & Plastic Surgery · 53d
Cleared Dec 21, 1999
SNN FLUORO NAVIGATION SYSTEM
K993673 · HAW
I.S.G. Technologies, Inc.
Neurology · 50d
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