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
161809–161832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1981
NEUROSPONGES
K812391 · GDY
Winn Hirsch & Assoc.
General & Plastic Surgery · 96d
Cleared Nov 24, 1981
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626 · JBQ
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 70d
Cleared Nov 24, 1981
ACA FIBRINOGEN CALIBRATOR
K812628 · GFX
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 70d
Cleared Nov 24, 1981
PORTABLE MEDICAL TABLE
K812791 · KXJ
Richard D. Spradlin
Radiology · 49d
Cleared Nov 24, 1981
SILASTIC VOICE PROSTHESIS
K812864 · EWL
Dow Corning Corp. Healthcare...
Ear, Nose, Throat · 42d
Cleared Nov 24, 1981
OHIO NON-REUSABLE TRACHEAL TUBE MURPHY
K812879 · BTR
Airco/Ohio Medical Products
Anesthesiology · 41d
Cleared Nov 24, 1981
OHIO NON-REUSABLE TRACHEAL TUBE MAJILL
K812880 · BTR
Airco/Ohio Medical Products
Anesthesiology · 41d
Cleared Nov 24, 1981
DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM
K812885 · KIT
Dutchland Laboratories, Inc.
Microbiology · 41d
Cleared Nov 24, 1981
ELECTRO-GONIOMETER
K812908 · KQX
Chattanooga Group, Inc.
Neurology · 36d
Cleared Nov 24, 1981
OMEGA II ANGIOGRAPHIC TABLE
K812913 · IZI
General Electric Co.
Radiology · 36d
Cleared Nov 24, 1981
MX 125
K812915 · ITY
General Electric Co.
Radiology · 36d
Cleared Nov 24, 1981
3.5 MHZ BIOPSY TRANSDUCER
K812929 · ITX
General Electric Co.
Radiology · 36d
Cleared Nov 24, 1981
IBIS II
K812963 · JAA
Cgr Medical Corp.
Radiology · 33d
Cleared Nov 24, 1981
400T ECT SOFTWARE
K812966 · JWM
General Electric Co.
Radiology · 33d
Cleared Nov 24, 1981
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS
K812979 · CGN
Amersham Corp.
Chemistry · 32d
Cleared Nov 24, 1981
BLOM-SINGER VOICE PROSTHESIS
K812982 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 32d
Cleared Nov 24, 1981
KODAK CINEFLUOROGRAPHIC FILM SO-274
K813005 · IWZ
Eastman Kodak Company
Radiology · 28d
Cleared Nov 24, 1981
ZEE TRACTION SPLINT
K813016 · HST
Zee Medical Products Co., Inc.
Neurology · 28d
Cleared Nov 24, 1981
ZIKON 100 DIGITAL X-RAY SYSTEM
K813032 · JAB
Kontron Instruments, Inc.
Radiology · 27d
Cleared Nov 24, 1981
COMPTAR III
K813051 · IZO
Cgr Medical Corp.
Radiology · 26d
Cleared Nov 24, 1981
SPINAL WRENCH
K813067 · HXC
Twin City Surgical, Inc.
Orthopedic · 25d
Cleared Nov 24, 1981
COMPOSITE DENTAL RESTORATIVE MATERIAL
K813090 · EBF
Sci-Pharm, Inc.
Dental · 22d
Cleared Nov 24, 1981
FISSURE SEALER & BONDING AGENT
K813091 · EBC
Sci-Pharm, Inc.
Dental · 22d
Cleared Nov 24, 1981
BACK RIE
K813099 · ION
Back Rite
Physical Medicine · 21d