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
150217–150240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1984
INRA MENEZO B2 MEDIA
K844288 · KIT
Fcs Laboratories, Inc.
Hematology · 38d
Cleared Dec 13, 1984
MIST-EASE NEBULIZER
K844591 · CCQ
General Physiotherapy, Inc.
Anesthesiology · 17d
Cleared Dec 12, 1984
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886 · GWN
Teca, Inc.
Neurology · 142d
Cleared Dec 12, 1984
MED. DYNAMICS SATICAN VIDEO CAMERA 5410
K843294 · KQM
Medline Industries, Inc.
General & Plastic Surgery · 113d
Cleared Dec 12, 1984
MED. DYNAMICS HIGH RESOLUTION SOLID ST
K843295 · KQM
Medline Industries, Inc.
General & Plastic Surgery · 113d
Cleared Dec 12, 1984
HEMOTEC ACT I SYSTEM
K843459 · JBP
Hemotec, Inc.
Hematology · 98d
Cleared Dec 12, 1984
TRI-COUNT LASER
K843485 · JPK
Hematology Marketing Assoc.
Hematology · 97d
Cleared Dec 12, 1984
UROPAPER EIKEN 8
K843532 · KHE
Syn-Kit, Inc.
Chemistry · 96d
Cleared Dec 12, 1984
ORTHO BRAIN THROMBOPLASTIN DILUENT
K843535 · GJS
Ortho Diagnostic Systems, Inc.
Hematology · 96d
Cleared Dec 12, 1984
AMS ANA CARD
K843686 · JSP
Vitek Systems, Inc.
Microbiology · 85d
Cleared Dec 12, 1984
VIS-1000 VIDEO SYSTEM
K843806 · KQM
Vistek Corp.
General & Plastic Surgery · 76d
Cleared Dec 12, 1984
ESCHMANN TDB50 BIPOLAR COAGULATION
K844004 · GEI
Storz Instrument Co.
General & Plastic Surgery · 61d
Cleared Dec 12, 1984
DOSIMETRIC RELEASE IN THE PROCESSING OF GAMMA STER
K844462
Washington-Greene County Branch...
General & Plastic Surgery · 27d
Cleared Dec 12, 1984
80 MG/DL GLUCOSE CONTROL
K844581 · JIS
Boehringer Mannheim Corp.
Chemistry · 19d
Cleared Dec 12, 1984
C.A.S.E. CONTAINER
K844652 · FSM
General Medical Co.
General & Plastic Surgery · 13d
Cleared Dec 12, 1984
SHARP COLLECTION SYSTEM-SHARP-A-GATOR
K844654 · MMK
Devon Industries, Inc.
General Hospital · 13d
Cleared Dec 12, 1984
DIXON SCISSORS, STARINLESS STEEL, OPERATING TYPE
K844667
William Dixon Co.
Dental · 12d
Cleared Dec 12, 1984
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
K844720 · JQB
Data Medical Associates, Inc.
Chemistry · 8d
Cleared Dec 11, 1984
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
K841654 · DSH
Del Mar Avionics
Cardiovascular · 232d
Cleared Dec 11, 1984
ULTRASONIC LITHOTRIPTOR 300A
K842024 · FEO
Fibra Sonics, Inc.
Gastroenterology & Urology · 207d
Cleared Dec 11, 1984
MULTIPLE LENS, SPECTACLES, CUSTOM
K842187 · HQG
Pavuna , Ltd.
Ophthalmic · 190d
Cleared Dec 11, 1984
MULTIPLE-LENS, SPECTACLES, CUSTOM
K842188 · HQE
Gold Cadillac Co.
Ophthalmic · 190d
Cleared Dec 11, 1984
MULTIPLE LENS, SPECTACLES CUSTOM
K842189 · HQG
Hanmy Optical Industrial Co.
Ophthalmic · 190d
Cleared Dec 11, 1984
CARE 5000 CENTRAL MONITOR MS5220 ETC.
K842582 · DRT
Care Monitoring Systems
Cardiovascular · 161d