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
112465–112488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1993
ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP
K930190 · JWH
Dow Corning Wright
Orthopedic · 200d
Cleared Aug 02, 1993
ELECTRIC WIRE DRIVER, MODEL 2640E
K930205 · HXJ
Micro Surgical Instruments Corp.
Orthopedic · 199d
Cleared Aug 02, 1993
SPECTACLE FRAMES
K930597 · HQZ
Venis DI Alessandro Vendrame
Ophthalmic · 178d
Cleared Aug 02, 1993
PREMIUM
K930673 · FNM
Kinetic Concepts, Inc.
General Hospital · 174d
Cleared Aug 02, 1993
MEDI-DYNE ANGIOGRAPHIC CATHETER
K930694 · DQO
Medi-Dyne, Inc.
Cardiovascular · 173d
Cleared Aug 02, 1993
ALTAIR EYEWEAR FRAMES
K931135 · HQZ
Altair Eyewear
Ophthalmic · 150d
Cleared Aug 02, 1993
DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET
K932870 · JJX
Casco Standards
Chemistry · 49d
Cleared Aug 02, 1993
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
K932955 · JLS
Ciba Corning Diagnostics Corp.
Chemistry · 46d
Cleared Aug 02, 1993
GOLD ASP MODULE, ITE
K933036 · ESD
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD K AMP, ITE
K933037 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD AF MODULE, ITE
K933038 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD L MODULE, ITE
K933039 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
GOLD CD MODULE, ITE
K933040 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
COLD CD ASP MODULE, ITE
K933041 · LRS
Electone, Inc.
General & Plastic Surgery · 96d
Cleared Aug 02, 1993
SILVER COMPRESSION MODULE, ITE
K933042 · ESD
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER PPP MODULE, ITE
K933043 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER LD MODULE, ITE
K933044 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER RECHARGEABLE MODULE, ITE
K933045 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SILVER L MODULE, ITE
K933046 · LRB
Electone, Inc.
Ear, Nose, Throat · 96d
Cleared Aug 02, 1993
SPECTACLE FRAMES
K933133 · HQZ
Solitaire Designs, Ltd.
Ophthalmic · 35d
Cleared Jul 30, 1993
THE MEDIC TM
K920912 · GCX
Medical and Environment Designs, Inc.
General Hospital · 519d
Cleared Jul 30, 1993
BAL CATH
K923487 · KTR
Ballard Medical Products
Ear, Nose, Throat · 380d
Cleared Jul 30, 1993
LAPAROSCOPIC NERVE HOOK
K924372 · GCJ
Nusurg, Inc.
General & Plastic Surgery · 336d
Cleared Jul 30, 1993
STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH
K924677 · LJS
Strato Medical Corp.
General Hospital · 317d