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
74137–74160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS...
K022072 · CIX
Precision Systems, Inc.
Chemistry · 58d
Cleared Aug 23, 2002
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
K022239 · JAK
Praxim
Radiology · 43d
Cleared Aug 23, 2002
LITE MINERAL OIL
K022332 · MQL
Intl., Inc.
Obstetrics & Gynecology · 36d
Cleared Aug 23, 2002
ALLGRAD AND ALLGRAD100
K022335 · MQL
Intl., Inc.
Obstetrics & Gynecology · 36d
Cleared Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 35d
Cleared Aug 23, 2002
UNI KNEE
K022437 · HRY
Encore Medical, L.P.
Orthopedic · 29d
Cleared Aug 23, 2002
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
K022487 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Aug 23, 2002
MODEL OBC-63 BREAST ARRAY COIL
K022488 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Aug 23, 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507 · MSX
Datex-Ohmeda
Cardiovascular · 24d
Cleared Aug 23, 2002
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · JIR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Aug 23, 2002
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K022554 · JXG
Integra Neurosciences
Neurology · 21d
Cleared Aug 23, 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K022561 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 23, 2002
ENDIUS FLEXTIP BLADE
K022578 · HRX
Endius, Inc.
Orthopedic · 18d
Cleared Aug 23, 2002
MODIFICATION TO MEDAMICUS AXIA RSN
K022689 · DYB
Medamicus, Inc.
Cardiovascular · 10d
Cleared Aug 22, 2002
NANMA ADJUSTABLE CONSTRICTION RING
K013051 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 345d
Cleared Aug 22, 2002
ULTRASTIM KIT
K013532 · GZJ
Axelgaard Mfg. Co., Ltd.
Neurology · 309d
Cleared Aug 22, 2002
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT
K020226 · JWZ
Hellen Professional Services
Microbiology · 212d
Cleared Aug 22, 2002
ARTERIA BLOOD FILTER
K021293 · FPB
Arteria Medical Science, Inc.
General Hospital · 121d
Cleared Aug 22, 2002
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION...
K022102 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 55d
Cleared Aug 22, 2002
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 52d
Cleared Aug 22, 2002
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
K022397 · LNH
GE Medical Systems
Radiology · 30d
Cleared Aug 22, 2002
DISPOSABLE PRESSURE MANOMETER
K022402 · CAP
Vital Signs, Inc.
Anesthesiology · 30d
Cleared Aug 22, 2002
CONTOUR SE MICROSPHERES
K022427 · HCG
Boston Scientific Corp
Neurology · 28d
Cleared Aug 22, 2002
S2 FEMORAL NAIL
K022461 · HSB
Howmedica Osteonics
Orthopedic · 27d