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
119353–119376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1991
MODEL 330 SCREENING AUDIOMETER
K911689 · EWO
Virtual Corp.
Ear, Nose, Throat · 188d
Cleared Oct 21, 1991
MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM
K912180 · IZX
Instrumentarium Imaging, Inc.
Radiology · 158d
Cleared Oct 21, 1991
EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE
K912492 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 139d
Cleared Oct 21, 1991
MERIT MANIFOLD
K913161 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 96d
Cleared Oct 21, 1991
MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS
K913266 · GEY
Micro Surgical Instruments Corp.
General & Plastic Surgery · 90d
Cleared Oct 21, 1991
MICROTEK MEDICAL'S SOUND STIKS
K913276 · EWO
Microbio-Medics, Inc.
Ear, Nose, Throat · 90d
Cleared Oct 21, 1991
LIMA RPS SHOULDER
K913282 · HSD
Turnkey Intergration USA, Inc.
Orthopedic · 89d
Cleared Oct 21, 1991
MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT
K913441 · LNH
Mri Devices Corp.
Radiology · 80d
Cleared Oct 21, 1991
GLOBALCARE EMS
K913444 · IPF
Globalcare Intl., Inc.
Physical Medicine · 80d
Cleared Oct 21, 1991
NIDEK MODELS AC-2100 & 2200
K913465 · GEX
Nidek, Inc.
General & Plastic Surgery · 77d
Cleared Oct 21, 1991
LOOK VISCODISSECTOR
K913530 · HQC
Look, Inc.
Ophthalmic · 74d
Cleared Oct 21, 1991
LIPASE LINEARITY CONTROL
K913585 · JJX
Creative Laboratory Products, Inc.
Chemistry · 70d
Cleared Oct 21, 1991
DR. DEAN EDELL SOLARBLOC SUNGLASSES
K913640 · HQY
Cable Car Sunglasses
Ophthalmic · 68d
Cleared Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET B
K913740 · DKB
Instrumentation Laboratory CO
Toxicology · 62d
Cleared Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET C
K913741 · DKB
Instrumentation Laboratory CO
Toxicology · 62d
Cleared Oct 21, 1991
CARDIO 500
K913754 · LLZ
Kontron Elektronik GmbH
Radiology · 61d
Cleared Oct 21, 1991
FLO-GARD(R) 6200, 6300 & 8000
K913895 · FRN
Baxter Healthcare Corp
General Hospital · 52d
Cleared Oct 21, 1991
F21(R) DENTAL CEMENT
K914073 · EMA
Voco GmbH
Dental · 40d
Cleared Oct 21, 1991
8000 SERIES VOLUMETRIC PUMP SOLUTION SET
K914074 · FPA
Baxter Healthcare Corp
General Hospital · 40d
Cleared Oct 21, 1991
ABBOTT QUICKSTART LD-1,#5A30
K914261 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 21, 1991
ACT-II BEHIND THE EAR HEARING AID
K914418 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 18d
Cleared Oct 21, 1991
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
K914477 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 13d
Cleared Oct 18, 1991
BIOKIT RPR
K910541 · GMQ
Biokit USA, Inc.
Microbiology · 256d
Cleared Oct 18, 1991
MF-500, MODIFICATION
K911144 · QGH
Elcot, Inc.
Neurology · 235d