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
154993–155016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1983
DIGITAL INJECTOR SYS
K833138 · DXT
Sybron Corp.
Cardiovascular · 61d
Cleared Nov 14, 1983
BOYLE SYSTEM ANESTHESIA GAS MACHINE
K833151 · BSZ
Fraser Harlake, Inc.
Anesthesiology · 60d
Cleared Nov 14, 1983
GONOCHEK-II
K833180 · JSX
E-Y Laboratories, Inc.
Microbiology · 56d
Cleared Nov 14, 1983
LACTABACILLUS AGAR W/O TWEEN80
K833292
Acumedia Manufacturers, Inc.
Microbiology · 53d
Cleared Nov 14, 1983
LABOR/DELIVERY/RECOVERY BED LDR-600
K833321 · KNC
Adel Medical , Ltd.
Obstetrics & Gynecology · 49d
Cleared Nov 14, 1983
SPECIFIC ATLAS MICROJUST
K833324
Haygood Scientific Tool Co.
Physical Medicine · 48d
Cleared Nov 14, 1983
MUTO BRUSH
K833330 · FDX
Microvasive
Gastroenterology & Urology · 48d
Cleared Nov 14, 1983
ASPIRATION & IRRIGATION CATHETER
K833331 · OCX
Microvasive
Gastroenterology & Urology · 48d
Cleared Nov 14, 1983
BEHIND THE EAR ASP-BB
K833334 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 48d
Cleared Nov 14, 1983
MODULUS II ANESTHESIA GAS MACHINE
K833335 · BSZ
Ohio Medical Products
Anesthesiology · 48d
Cleared Nov 14, 1983
TEL-STAR NUWAY & GENERIC E ASP-BP
K833451 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 40d
Cleared Nov 14, 1983
CASE-II
K833458 · DPS
Marquette Electronics, Inc.
Cardiovascular · 39d
Cleared Nov 14, 1983
PANASONIC WH-50 HEARING AID
K833510 · ESD
Panasonic Co. Div. Matsu Elec. Corp....
Ear, Nose, Throat · 34d
Cleared Nov 14, 1983
BOUINS SOLUTION
K833515 · IGN
Sigma Chemical Co.
Pathology · 34d
Cleared Nov 14, 1983
DISPOSABLE ARTHROSCOPY BLADE
K833587 · HRX
Dyonics, Inc.
Orthopedic · 33d
Cleared Nov 14, 1983
VASCULAR LABORATORY TREADMILL VT1
K833588 · IOL
Medasonics, Inc.
Physical Medicine · 33d
Cleared Nov 08, 1983
INTRAVASCULAR CATHETER
K831988 · FOS
C.R. Bard, Inc.
General Hospital · 140d
Cleared Nov 08, 1983
INSPIROMETER
K833012 · BWF
Kinetix
Anesthesiology · 63d
Cleared Nov 07, 1983
PHOENIX 60/60 PROCESSOR MODULE
K831134 · DSF
Phoenix Corp.
Cardiovascular · 214d
Cleared Nov 07, 1983
DINAMAP VITAL SIGNS MONITOR #1846P
K832656 · DXN
Critikon Company, LLC
Cardiovascular · 91d
Cleared Nov 07, 1983
DISPOSABLE MANIFOLD SET
K832657 · DRS
Mallinckrodt Critical Care
Cardiovascular · 91d
Cleared Nov 07, 1983
ARRHYTHMIA III CARDULE #1919
K832693 · DSI
Spacelabs, Inc.
Cardiovascular · 89d
Cleared Nov 07, 1983
BACK MASSAGER B-400 ADJUSTABLE
K832913 · ISA
Pollenex Associated Mills, Inc.
Physical Medicine · 70d
Cleared Nov 07, 1983
INTERMITTENT COMPRESSION PUMPS
K832920 · IRP
Chattanooga Group, Inc.
Physical Medicine · 77d