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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90025–90048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 10, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · MNH
United States Surgical, A Division of...
Orthopedic · 82d
Cleared Mar 10, 1998
DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL
K974781 · HSB
Depuy, Inc.
Orthopedic · 78d
Cleared Mar 10, 1998
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
K974844 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 76d
Cleared Mar 10, 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980026 · CFR
Trace America, Inc.
Chemistry · 64d
Cleared Mar 10, 1998
HEAT STACK
K980086 · LGZ
Medical Solutions, Inc.
General Hospital · 60d
Cleared Mar 10, 1998
EPILASER I UPGRADE KIT
K980160 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 53d
Cleared Mar 09, 1998
NP MEDICAL CAPLESS LUER ACTIVATED VALVE
K973916 · FPA
Np Medical, Inc.
General Hospital · 146d
Cleared Mar 09, 1998
SYNERGY
K974465 · EBF
Coltene/Whaledent, Inc.
Dental · 103d
Cleared Mar 09, 1998
H2O
K974587 · OLV
Grass-Telefactor Product Group
Neurology · 90d