FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79369–79392 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2001
THE MAESTRO SYSTEM
K010458 · DZE
BioHorizons Implant Systems, Inc.
Dental · 83d
Cleared May 10, 2001
BECKMAN COULTER DNASE B CALIBRATOR
K010696 · JIS
Beckman Coulter, Inc.
Immunology · 63d
Cleared May 10, 2001
BRIDGE III RECEIVER
K010794 · DXH
Meridian Medical Technologies , Ltd.
Cardiovascular · 55d
Cleared May 10, 2001
DENTO-PREP PARTICLE MICROBLASTER
K010816 · KOJ
Ronvig A/S
Dental · 52d
Cleared May 10, 2001
UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K010879 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 48d
Cleared May 10, 2001
RD-3008
K011036 · EJT
Heraeus Kulzer, Inc.
Dental · 35d
Cleared May 10, 2001
MANDREL GUIDEWIRE ASSEMBLY
K011084 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
K011163 · JXN
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
K011164 · KXS
Syva Co., Dade Behring, Inc.
Toxicology · 24d
Cleared May 10, 2001
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
K011166 · KLS
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 09, 2001
MP3HD BIG BOY, POWER WHEELCHAIR
K010380 · ITI
Merits Health Products., Inc.
Physical Medicine · 90d
Cleared May 09, 2001
RUSCH MMG/O'NEIL CATHETER
K010420 · FCM
Rusch, Inc.
Gastroenterology & Urology · 86d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · HWC
Mitek Products
Orthopedic · 68d
Cleared May 09, 2001
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND...
K011065 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 30d
Cleared May 09, 2001
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
K011077 · KNT
Andersen Products, Inc.
Gastroenterology & Urology · 30d
Cleared May 08, 2001
ENVOY PATIENT MONITOR
K001120 · DSI
Mennen Medical , Ltd.
Cardiovascular · 396d
Cleared May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · KWQ
Aesculap, Inc.
Orthopedic · 239d
Cleared May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · MQP
Depuyacromed
Orthopedic · 221d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · MNI
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared May 08, 2001
CLARIS PLATE SYSTEM
K010369 · MNH
Ortho Tec, LLC
Orthopedic · 90d
Cleared May 08, 2001
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
K010472 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 77d
Cleared May 08, 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
K010479 · HTY
Bonutti Research, Inc.
Orthopedic · 77d
Cleared May 08, 2001
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
K010542 · HAW
Surgical Navigation Specialists, Inc.
Neurology · 74d
Cleared May 08, 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
K010595 · HWC
Dj Orthopedics, LLC
Orthopedic · 69d