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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
158833–158856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1982
ACUSCREEN
K822782 · GGW
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Oct 08, 1982
GABRIEL DIGITREND
K822795 · HCS
Gabriel Ent.
Neurology · 22d
Cleared Oct 08, 1982
TDX KENAMYCIN
K822808 · KJI
Abbott Laboratories
Toxicology · 21d
Cleared Oct 08, 1982
EMG 100T
K822814 · HCC
Thought Technology , Ltd.
Neurology · 18d
Cleared Oct 08, 1982
INSTA-HOLD
K822847 · KKX
Taub Industries
General Hospital · 15d
Cleared Oct 07, 1982
MM-22 MICROTRON
K827704
Instrument AB Scanditronix
Radiology · 90d
Cleared Oct 07, 1982
DYNEX ULTRASOUND DIAGNOSTIC SCANNER
K827744
Elscint, Inc.
Radiology · 23d
Cleared Oct 07, 1982
DIGITAL RADIOGRAPHY EXAMINATION TABLE
K828313
Engineering Dynamics Corp.
Radiology · 15d
Cleared Oct 06, 1982
EXER-STIM CONTROLLER
K822056 · IPF
Th Charters, Inc.
Physical Medicine · 85d
Cleared Oct 06, 1982
RESPIRATION MONITOR TYPE MR-10
K822077 · FLS
New Dimensions IN Medicine, Inc.
Anesthesiology · 83d
Cleared Oct 06, 1982
EAR CANNULAS
K822201 · FGY
Kelleher Corp.
General & Plastic Surgery · 75d
Cleared Oct 06, 1982
COOPER VISION I/A SYSTEM III MODEL 1500
K822220 · HQE
CooperVision, Inc.
Ophthalmic · 72d
Cleared Oct 06, 1982
COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA
K822386 · FII
Hospal Medical Corp.
Gastroenterology & Urology · 58d
Cleared Oct 06, 1982
ODONTO-SCOPE
K822562 · FSO
Treace Medical, Inc.
General & Plastic Surgery · 43d
Cleared Oct 06, 1982
TYMPANOPLASTY & SKIN DISSECTORS
K822569 · GDI
Kelleher Corp.
General & Plastic Surgery · 43d
Cleared Oct 06, 1982
KEATES I/A SYSTEM FRIGITRONICS 4000
K822599 · HKP
Frigitronics of Connecticut, Inc.
Ophthalmic · 40d
Cleared Oct 06, 1982
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K822624 · IKN
Del Mar Avionics
Neurology · 37d
Cleared Oct 06, 1982
PILLING COIN-STYLE BLADE GAUGE
K822748
Narco Scientific
General & Plastic Surgery · 26d
Cleared Oct 06, 1982
PILLING DIAMOND KNIFE
K822749 · GDX
Narco Scientific
General & Plastic Surgery · 26d
Cleared Oct 06, 1982
UNIVERSAL DYNASPLINT
K822767 · IQI
Dynasplint Systems, Inc.
Physical Medicine · 22d
Cleared Oct 06, 1982
THORATEC GAS SAMPLING CONNECTOR
K822769 · CAI
Thoratec Laboratories Corp.
Anesthesiology · 22d
Cleared Oct 06, 1982
101 NEER TYPE SHOULDER
K822771 · HSD
Intermedics Orthopedics
Orthopedic · 22d
Cleared Oct 06, 1982
CERVICAL BRACE
K822780 · JEC
Jerome Medical
Orthopedic · 22d
Cleared Oct 06, 1982
FLEX ICE FREEZE PACK
K822783 · IME
Igloo Corp.
Physical Medicine · 22d