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
153577–153600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1984
DENTAL ULTRASONIC SCALER/ENDOSONIC
K840141 · ELC
CooperVision, Inc.
Dental · 71d
Cleared Mar 16, 1984
DIGITAL FLUOROGRAPHY X-RAY SYSTEM
K840191 · JAA
Adac Laboratories
Radiology · 58d
Cleared Mar 16, 1984
MOTOR TILTED EXAM. TABLE UV-56
K840226 · IXR
Medicor USA , Ltd.
Radiology · 57d
Cleared Mar 16, 1984
CEHPALOMETRIC HEAD POSITIONER
K840275 · EAH
Gary E. Hall, Dds
Radiology · 53d
Cleared Mar 16, 1984
URETHRAL CATH. TRAY W/BAG
K840292 · KNX
Corpak Co.
Gastroenterology & Urology · 52d
Cleared Mar 16, 1984
COLTENE ORALLOY MAGICAPS
K840297 · EJJ
Coltene, Inc.
Dental · 52d
Cleared Mar 16, 1984
CATEGORY 6 OPTHALMIC DEVICES
K840310 · HOB
Imm Enterprises , Ltd.
Ophthalmic · 52d
Cleared Mar 16, 1984
ENDODYNE DUAL
K840321 · LIH
Elmed, Inc.
Neurology · 51d
Cleared Mar 16, 1984
INLINE FOAM NOSE
K840398 · BYD
Mallinckrodt Critical Care
Anesthesiology · 46d
Cleared Mar 16, 1984
FOAM NOSE
K840399 · BYD
Mallinckrodt Critical Care
Anesthesiology · 46d
Cleared Mar 16, 1984
STERILIZED DISPOS. CYSTOTOME
K840442 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 44d
Cleared Mar 16, 1984
NEONATE MASK FOR BABIES
K840444 · HOY
Richards Medical Co., Inc.
Ophthalmic · 44d
Cleared Mar 16, 1984
EYE SPEAR
K840471 · HOZ
Surgicot, Inc.
Ophthalmic · 42d
Cleared Mar 16, 1984
PORTABLE TRANSIT CHAIR
K840638 · INM
Poirier S.A.
Physical Medicine · 56d
Cleared Mar 16, 1984
ANTERIOR CAPSULECTOMY CYSTITOME
K840659 · HNY
Sharpoint, Inc.
Ophthalmic · 30d
Cleared Mar 16, 1984
POSTERIOR CAPSULOTOMY CYSTITOME
K840660 · HNY
Sharpoint, Inc.
Ophthalmic · 30d
Cleared Mar 16, 1984
UXM MODEL 8188
K840678 · IZX
Universal X-Ray
Radiology · 30d
Cleared Mar 16, 1984
POWERMAT VRP-1 X-RAY IMAGING
K840698 · IWZ
Powers Chemco, Inc.
Radiology · 29d
Cleared Mar 16, 1984
ENDO-SECURE
K840844 · JAY
Exidyne, Inc.
Anesthesiology · 21d
Cleared Mar 16, 1984
OXYGEN TUBING
K840897 · CAT
Medical Technologies of Georgia
Anesthesiology · 18d
Cleared Mar 16, 1984
PALL COALESCER
K840960 · CAH
Pall Biomedical Products Co.
General Hospital · 10d
Cleared Mar 15, 1984
BIO-BAND BANDAGES
K822306 · FRO
Robert Hirschfield
General & Plastic Surgery · 594d
Cleared Mar 15, 1984
DISPOSABLE FIBER OPTIC ILLUMINATOR
K833465 · HQC
CooperVision, Inc.
Ophthalmic · 162d
Cleared Mar 15, 1984
TITAN GEL LIPOPROTEIN ELECTROPHORESIS
K833611 · JHO
Helena Laboratories
Chemistry · 154d