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
75673–75696 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2002
PHILIPS PLS9W/12/2P UVB
K021514 · FTC
Philips Lighting Co.
General & Plastic Surgery · 7d
Cleared May 15, 2002
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
K020538 · DWL
Boehringer Laboratories
General Hospital · 85d
Cleared May 15, 2002
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
K020633 · HIS
Ls Rubber Sdn Bhd
Obstetrics & Gynecology · 77d
Cleared May 15, 2002
HERNIAMESH T-SLING
K020652 · PAH
Herniamesh
Gastroenterology & Urology · 76d
Cleared May 15, 2002
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
K020726 · HIB
Dukal Corp.
Obstetrics & Gynecology · 70d
Cleared May 15, 2002
ACON ONE STEP DRUG SCREEN TEST CARD
K020771 · DIO
ACON Laboratories, Inc.
Toxicology · 68d
Cleared May 15, 2002
VITAL SCIENTIFIC PT WITH CALCIUM
K020840 · GJS
Vital Scientific N.V.
Hematology · 61d
Cleared May 15, 2002
ERTAPENEM 10UG BBL SENSI-DISC
K020842 · JTN
Becton, Dickinson & CO
Microbiology · 61d
Cleared May 15, 2002
CEFOTAXIME
K020859 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 58d
Cleared May 15, 2002
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS
K021042 · MQG
Thermo Forma, Inc.
Obstetrics & Gynecology · 44d
Cleared May 15, 2002
FORTAFLEX SURGICAL SLING
K021107 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 40d
Cleared May 15, 2002
UNI-PATCH ULTRASOUND COUPLING GEL
K021132 · MUI
The Ludlow Company LP
Radiology · 36d
Cleared May 15, 2002
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
K021175 · CAF
Aerogen, Inc.
Anesthesiology · 33d
Cleared May 15, 2002
BIO-LOGIC ABAER CUB
K021215 · GWJ
Bio-Logic Systems Corp.
Neurology · 28d
Cleared May 15, 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK...
K021228 · DQX
Guidant Corp.
Cardiovascular · 27d
Cleared May 15, 2002
SURGASSIST FLEXSHAFT 2, MODEL FS2 14
K021249 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 26d
Cleared May 15, 2002
MODIFICATION TO SPARC SLING SYSTEM
K021263 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared May 15, 2002
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · BTA
Medela AG
General & Plastic Surgery · 15d
Cleared May 15, 2002
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
K021422 · MHX
Philips Medical Systems
Cardiovascular · 12d
Cleared May 14, 2002
REPROCESSED COMPRESSION LIMB SLEEVES
K012658 · JOW
Surgical Instruments Service and...
Cardiovascular · 274d
Cleared May 14, 2002
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
K013587 · KKO
Babies Best, Inc.
Dental · 196d
Cleared May 14, 2002
NYCOCARD CRP
K013787 · DCK
Primus Corp.
Chemistry · 181d
Cleared May 14, 2002
MICROJET CRONO PAR AND CRONO APO-GO
K013840 · FRN
Cane S.R.L.
General Hospital · 176d
Cleared May 14, 2002
LATEX SURGEONS GLOVE (POWDERED)
K014278 · KGO
Brightway Gloves Pvt. , Ltd.
General Hospital · 138d