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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
148105–148128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1985
PHACO PAK I
K851211 · HQC
United Sonics, Inc.
Ophthalmic · 71d
Cleared Jun 05, 1985
RADIAL IMMUNODIFFUSION PLATES C3 & C4
K851286 · CZW
Cooper Biomedical, Inc.
Immunology · 65d
Cleared Jun 05, 1985
RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR
K851440 · IXY
Summit Industries, Inc.
Radiology · 56d
Cleared Jun 05, 1985
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537 · DHR
Behring Diagnostics, Inc.
Immunology · 50d
Cleared Jun 05, 1985
IMPACT TURBO CATH
K851611 · JOL
Impact Instrumentation, Inc.
General Hospital · 57d
Cleared Jun 05, 1985
APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1
K851649 · DER
Photec Diagnostics, Inc.
Immunology · 44d
Cleared Jun 05, 1985
DIGITAL GAMMA CAMERA GCA 501S
K851686 · JWM
Toshiba Medical Systems
Radiology · 43d
Cleared Jun 05, 1985
JUMBO DIGITAL GAMMACAMERA GCA-90B
K851687 · JWM
Toshiba Medical Systems
Radiology · 43d
Cleared Jun 05, 1985
ULTRA-NEB 100 ULTRASONIC NEBULIZER
K851695
The Devilbiss Co.
Cardiovascular · 44d
Cleared Jun 05, 1985
DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711
K851812 · IXF
Victoreen, Inc.
Radiology · 40d
Cleared Jun 05, 1985
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K851842 · DCK
Atlantic Antibodies
Immunology · 40d
Cleared Jun 05, 1985
STERILE ENDOTRACHEAL BRUSHES
K851851
Biological & Environmental Control...
Cardiovascular · 40d
Cleared Jun 05, 1985
A COMPANY BRASS SEPARATING RINGS
K851878 · DZC
A Company, Inc.
Dental · 37d
Cleared Jun 05, 1985
BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD
K852019 · EAP
Belmont Equipment Corp.
Radiology · 28d
Cleared Jun 05, 1985
ACC CROSS CYLINDERS
K852056 · HPC
Ascon Medical Instruments, Ltd.
Ophthalmic · 27d
Cleared Jun 05, 1985
ATF 101 TRAIL FRAME
K852126 · HPA
Ascon Medical Instruments, Ltd.
Ophthalmic · 21d
Cleared Jun 04, 1985
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
K844762 · GTJ
Wellcome Diagnostics
Immunology · 179d
Cleared Jun 04, 1985
NOMAD TM-3400
K850109 · GWF
Tracor Northern, Inc.
Neurology · 141d
Cleared Jun 04, 1985
TUTTNAUER PRE-VACUUM AUTOCLAVE
K850264 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 132d
Cleared Jun 04, 1985
CANAL FINDER
K850294 · EGS
Roseburg SA
Dental · 131d
Cleared Jun 04, 1985
FLEXIBLE FIBEROPTIC ENDOSCOPE
K850393
Microvasive
Gastroenterology & Urology · 123d
Cleared Jun 04, 1985
SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
K850435 · FKR
Sartorius Filters, Inc.
Gastroenterology & Urology · 120d
Cleared Jun 04, 1985
TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER
K851015 · EWO
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 84d
Cleared Jun 04, 1985
TENSMED II
K851063 · GZJ
Intermedics, Inc.
Neurology · 81d