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
73561–73584 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2002
ACUBEAM, SUPER NOVA, DIO
K022888 · ILY
Light Force Therapy, Inc.
Physical Medicine · 103d
Cleared Dec 11, 2002
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
K022928 · IYO
Hudson Diagnostic Imaging, LLC
Radiology · 98d
Cleared Dec 11, 2002
W.O.M. LASER U100
K023041 · GEX
W.O.M. World of Medicine AG
General & Plastic Surgery · 90d
Cleared Dec 11, 2002
PRESS-FIT HEAD RESURFACING DEVICE
K023188 · KXA
Biomet Orthopedics, Inc.
Orthopedic · 78d
Cleared Dec 11, 2002
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
K023232 · EFS
Smartpractice
Dental · 75d
Cleared Dec 11, 2002
T2 SUPRACONDYLAR NAIL SYSTEM
K023267 · HSB
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Dec 11, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K023299 · MNI
Alphatec Mfg., Inc.
Orthopedic · 69d
Cleared Dec 11, 2002
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
K023330 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 68d
Cleared Dec 11, 2002
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION...
K023379 · MQF
Cooper Surgical
Obstetrics & Gynecology · 64d
Cleared Dec 11, 2002
PORTADUR P2
K023395 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 63d
Cleared Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
K023597 · LTK
Beckman Coulter, Inc.
Immunology · 44d
Cleared Dec 11, 2002
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153,...
K023777 · HRX
Arthronet Medical, Inc.
Orthopedic · 29d
Cleared Dec 11, 2002
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
K023803 · DTB
Biotronik, Inc.
Cardiovascular · 27d
Cleared Dec 11, 2002
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · DWF
Ethicon, Inc.
Cardiovascular · 20d
Cleared Dec 11, 2002
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
K023923 · KNW
Senorx, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 11, 2002
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS...
K023928 · JJW
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Dec 11, 2002
GE PHOTON ENERGY RECOVERY (PER) OPTION
K023932 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Dec 10, 2002
CD HORIZON SPINAL SYSTEM
K014296 · KWP
Medtronic Sofamor Danek
Orthopedic · 344d
Cleared Dec 10, 2002
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
K020085 · MNH
Sintea Biotech, Inc.
Orthopedic · 334d
Cleared Dec 10, 2002
BD DIRECTIGEN EZ RSV KIT
K022133 · GQG
Becton, Dickinson & CO
Microbiology · 162d
Cleared Dec 10, 2002
SNORE-AID MAX
K022284 · LRK
Dental Imagineers, LLC
Dental · 148d
Cleared Dec 10, 2002
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION,...
K022377 · KWT
Implex Corp.
Orthopedic · 141d
Cleared Dec 10, 2002
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
K023019 · FGI
Vomed Volzer Medizintechnik GmbH & Co.
Gastroenterology & Urology · 90d
Cleared Dec 10, 2002
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR...
K023077 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 85d