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
87529–87552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1998
ABBOTT ARCHITECT TESTOSTERONE
K983212 · CDZ
Abbott Laboratories
Chemistry · 65d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
K983262 · KGI
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
K983268 · LFH
Diagnostic Reagents, Inc.
Toxicology · 62d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
K983269 · KGI
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
K983271 · KGI
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
G/K SFN AND STN LOCKING NAILS
K983358 · HSB
Howmedica, Inc.
Orthopedic · 55d
Cleared Nov 18, 1998
PRODIGY- 3
K983370 · EBF
Sybron Dental Specialties, Inc.
Dental · 55d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN...
K983376 · LLL
Zeus Scientific, Inc.
Immunology · 54d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN...
K983378 · LJM
Zeus Scientific, Inc.
Immunology · 54d
Cleared Nov 18, 1998
ONTRAK TESTCUP-ER
K983388 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Nov 18, 1998
IS-ANTI-MPO IGG ELISA TEST SYSTEM
K983390 · MOB
Columbia Bioscience, Inc.
Immunology · 54d
Cleared Nov 18, 1998
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST...
K983418 · DHR
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK...
K983420 · LKP
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED...
K983422 · LRM
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME...
K983423 · LLL
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME...
K983425 · LLL
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME...
K983426 · LLL
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
PROCERA ALLCERAM FUSING MATERIAL
K983453 · EIH
Nobel Biocare Uas, Inc.
Dental · 49d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME...
K983464 · LLL
Zeus Scientific, Inc.
Immunology · 48d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME...
K983465 · LKO
Zeus Scientific, Inc.
Immunology · 48d
Cleared Nov 18, 1998
QUADRANT UNIBOND
K983545 · KLE
Cavex Holland BV
Dental · 40d
Cleared Nov 18, 1998
OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
K983669 · HAW
Radionics, Inc.
Neurology · 30d
Cleared Nov 18, 1998
IS-ANTI-PR3 IGG ELISA TEST SYSTEM
K983740 · MOB
Columbia Bioscience, Inc.
Immunology · 27d
Cleared Nov 18, 1998
DIMENSION AHDL CALIBRATOR
K983850 · JIT
Dade Behring, Inc.
Chemistry · 19d