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
140617–140640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1987
DIAGNOSTIC ULTRASONIC TRANSDUCER
K863364 · ITX
Toshiba Medical Systems
Radiology · 178d
Cleared Feb 27, 1987
POREX(TM) EYE SPHERE IMPLANT
K863943 · HPZ
Porex Medical
Ophthalmic · 140d
Cleared Feb 27, 1987
POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT
K863946 · HQX
Porex Medical
Ophthalmic · 140d
Cleared Feb 27, 1987
SOLUSET CALCIUM DEMINERALIZING SOLUTION
K864976 · EKS
Endo Technic Corp.
Dental · 70d
Cleared Feb 27, 1987
MEDTRAC VP VOLUMETRIC INFUSION PUMP
K864997 · FRN
American Edwards Laboratories
General Hospital · 67d
Cleared Feb 27, 1987
INFUMIX MIXING CONTAINER
K870052 · KPE
Biodynamics Corp.
General Hospital · 51d
Cleared Feb 27, 1987
A+MED DISPOSABLE NEEDLE
K870193 · FMI
Can-Am Surgical Corp.
General Hospital · 38d
Cleared Feb 27, 1987
COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM
K870266 · EBF
Coltene, Inc.
Dental · 35d
Cleared Feb 27, 1987
STRYKER MODEL 977 BIRTHING BED
K870745 · KNC
Stryker Corp.
Obstetrics & Gynecology · 2d
Cleared Feb 26, 1987
FUJI CR IMAGING PLATE
K862414 · EAM
Parexel Intl. Corp.
Radiology · 246d
Cleared Feb 26, 1987
LADD/STERITEK ICP MONITOR, CAT. NO. P3000
K862820 · GWM
Ladd Research Industries, Inc.
Neurology · 216d
Cleared Feb 26, 1987
IUC - INTRAUTERINE CATHETER
K862873 · KXO
Utah Medical Products, Inc.
Obstetrics & Gynecology · 211d
Cleared Feb 26, 1987
CPREVIVER
K864125 · BTM
Augerscope, Inc.
Anesthesiology · 128d
Cleared Feb 26, 1987
SCHULDT* PLUS 8 T.E.N.S. DEVICE
K864368 · GZJ
Schuldt Laboratories, Inc.
Neurology · 113d
Cleared Feb 26, 1987
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · GTY
Abbott Laboratories
Microbiology · 83d
Cleared Feb 26, 1987
VIEW(TM) IMAGE PROCESSING AND VIEWING STATION
K864854 · LLZ
Virtual Imaging
Radiology · 77d
Cleared Feb 26, 1987
IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C
K865027 · MOT
Cis-Us, Inc.
Radiology · 65d
Cleared Feb 26, 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · GZJ
Medtronic Vascular
Neurology · 64d
Cleared Feb 26, 1987
STIMUTRON MODEL 100
K865054 · IPF
The Austin-Lenick Co.
Physical Medicine · 64d
Cleared Feb 26, 1987
FERRAY EXTRACTOR
K870083 · HWB
Terray Manufacturing, Inc.
Orthopedic · 49d
Cleared Feb 26, 1987
REDMAN ACCESSORIES
K870298 · KNO
Redman, Inc.
Physical Medicine · 29d
Cleared Feb 26, 1987
RUBYCELL(TM) SYNTHETIC ISLAND DRESSING
K870352 · FRO
Bioderm, Inc.
General & Plastic Surgery · 28d
Cleared Feb 26, 1987
ISE COMPENSATION SERA
K870379 · JIS
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Feb 26, 1987
GAUZE, ABSORBENT, IODOFORM IMPREGNATED
K870431 · FRO
Steridyne Laboratories, Inc.
General & Plastic Surgery · 23d