FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132937–132960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1989
AXOSTIM
K883807 · BXN
Singer Medical Products, Inc.
Anesthesiology · 154d
Cleared Feb 09, 1989
POLARIX 2 AND POLARIX 2E
K884578 · JAA
Dyna-Med
Radiology · 100d
Cleared Feb 09, 1989
CANDELA STONE BASKETS
K884738 · FFL
Candela Laser Corp.
Gastroenterology & Urology · 87d
Cleared Feb 09, 1989
CERVICAL BRUSH
K884873 · HHT
Statlab Medical Products, Inc.
Obstetrics & Gynecology · 80d
Cleared Feb 09, 1989
CENTURION(TM) MIXER
K884879 · BSZ
Matrix Medica, Inc.
Anesthesiology · 80d
Cleared Feb 09, 1989
HEMO-SANITAS SYRINGE
K884921 · FMF
Hemo-Sanitas, Inc. C/O Greenberg...
General Hospital · 73d
Cleared Feb 09, 1989
MENISCUS MENDER II LOOP
K885311 · HWQ
Instrument Makar, Inc.
Orthopedic · 42d
Cleared Feb 09, 1989
3D/DENTAL
K885322 · JAK
Columbia Scientific, Inc.
Radiology · 43d
Cleared Feb 08, 1989
CONTINUUM KNEE SYSTEM (CKS)
K882322 · JWH
Buckman Co., Inc.
Orthopedic · 247d
Cleared Feb 08, 1989
DACA-100
K882933 · LLZ
Visual Cybernetics
Radiology · 210d
Cleared Feb 08, 1989
VIRGO (R) CMV-IGG ELISA
K883102 · GQI
Electro-Nucleonics, Inc.
Microbiology · 201d
Cleared Feb 08, 1989
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
K883111 · FKP
Baxter Healthcare Corp
Gastroenterology & Urology · 198d
Cleared Feb 08, 1989
SURGITEK (R) UROFLOW SYSTEM
K883274 · FFG
Medical Engineering Corp.
Gastroenterology & Urology · 189d
Cleared Feb 08, 1989
THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)
K883412 · DWF
Promedica Products, Inc.
Cardiovascular · 177d
Cleared Feb 08, 1989
DERMASTRIP
K883660 · KGX
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 166d
Cleared Feb 08, 1989
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
K883661 · LWJ
Depuy, Inc.
Orthopedic · 166d
Cleared Feb 08, 1989
REPLICARE (ADDITIONAL CLAIMS)
K883849 · NAD
United Medical
General & Plastic Surgery · 149d
Cleared Feb 08, 1989
LAKE N/G FEEDING TUBE
K884127 · KNT
Lake Medical Products, Inc.
Gastroenterology & Urology · 131d
Cleared Feb 08, 1989
(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
K884723 · KQX
Greenleaf Medical Systems, Inc.
Neurology · 90d
Cleared Feb 08, 1989
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
K884789 · KWL
Protek, Inc.
Orthopedic · 85d
Cleared Feb 08, 1989
LUMED EXPANDO-CATH, ACTIV
K884806 · FOZ
Luther Medical Products, Inc.
General Hospital · 83d
Cleared Feb 08, 1989
INTERA SHIELD AND INTERA UNDERGARMENT
K885185 · EYQ
Intera Corp.
Gastroenterology & Urology · 56d
Cleared Feb 08, 1989
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT
K885195 · CDP
Amersham Corp.
Chemistry · 54d
Cleared Feb 08, 1989
FLUID DRAINAGE WICK
K885232 · HOZ
Visitec Co.
Ophthalmic · 50d