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
90529–90552 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1998
BRUXTRAK MATERIAL
K974160 · EBI
Bruxcare, LLC
Dental · 126d
Cleared Mar 11, 1998
MULTITEST CD3/CD8/CD45/CD4
K974360 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 112d
Cleared Mar 11, 1998
FRIALIT-2 PROTECT ABUTMENT
K974628 · DZE
Friatec AG
Dental · 90d
Cleared Mar 11, 1998
72 HOUR USE TRACH CARE WITH MICROBAN
K974630 · CAH
Ballard Medical Products
General Hospital · 89d
Cleared Mar 11, 1998
ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR
K974671 · EFB
Athena Technology, Inc.
Dental · 86d
Cleared Mar 11, 1998
REUSABLE FINGER SENSOR 3444
K974697 · DQH
Bci Intl., Inc.
Cardiovascular · 85d
Cleared Mar 11, 1998
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K974780 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 79d
Cleared Mar 11, 1998
CO-STAT(TM) END TIDAL BREATH ANALYZER
K974805 · GHS
Natus Medical, Inc.
Hematology · 78d
Cleared Mar 11, 1998
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE...
K980127 · FPA
Catheter Innovations, Inc.
General Hospital · 56d
Cleared Mar 11, 1998
BAUSCH & LOMB WETTING AND SOAKING SOLUTION
K980133 · LPN
Polymer Technology Corp.
Ophthalmic · 55d
Cleared Mar 11, 1998
FACEBOW
K980195 · DZB
Ortho Kinetics Corp.
Dental · 50d
Cleared Mar 11, 1998
IMPOWER EXTERNAL VACUUM SYSTEM
K980291 · LKY
Imagyn Medical Technologies, Inc.
Gastroenterology & Urology · 44d
Cleared Mar 11, 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318 · LYY
Hartalega Sdn Bhd
General Hospital · 43d
Cleared Mar 11, 1998
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
K980532 · LCX
Phamatech
Chemistry · 28d
Cleared Mar 10, 1998
SIBELMED AC50D
K973377 · EWO
Trutone
Ear, Nose, Throat · 183d
Cleared Mar 10, 1998
PYLORI DETECT IGG
K973508 · LYR
Micro Detect, Inc.
Microbiology · 175d
Cleared Mar 10, 1998
AEROETCHER
K973679 · KOJ
Parkell, Inc.
Dental · 165d
Cleared Mar 10, 1998
TEMPO AND TEMP H20
K973748 · LGZ
Smith
General Hospital · 160d
Cleared Mar 10, 1998
VIDAS D-DIMER (DD) ASSAY
K973819 · DAP
Biomerieux Vitek, Inc.
Hematology · 154d
Cleared Mar 10, 1998
ULTRABUR
K974174 · ERL
Mednet Locator, Inc.
Ear, Nose, Throat · 124d
Cleared Mar 10, 1998
PLAQUAGRAFE, AGRAFE P4V
K974603 · HRS
Atlas Technology
Orthopedic · 90d
Cleared Mar 10, 1998
CARBON FIBER BREAST BOARD
K974703 · IYE
Medtec, Inc.
Radiology · 84d
Cleared Mar 10, 1998
GEMINI STANDARD AND MINI VALVES
K974708 · JXG
Neurocare Group
Neurology · 83d
Cleared Mar 10, 1998
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K974723 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 82d