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
165217–165240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1980
CK-MB(IMMUNOLOGICAL)
K802521 · JHS
Biodynamics Corp.
Hematology · 28d
Cleared Nov 12, 1980
SURGICAL HAMMERS
K802524 · FZY
Midshore Welding Corp.
General & Plastic Surgery · 27d
Cleared Nov 12, 1980
GAMMA LEWIS BLOOD GROUP SUBSTANCE
K802533 · KSX
Gamma Biologicals, Inc.
Hematology · 28d
Cleared Nov 12, 1980
GAMMA PI BLOOD GROUP SUBSTANCE
K802534 · KSX
Gamma Biologicals, Inc.
Hematology · 28d
Cleared Nov 12, 1980
DISPOSABLE SURGICAL DRAPE
K802537 · KKX
Texas Medical Products, Inc.
General Hospital · 28d
Cleared Nov 12, 1980
EMERGENCY DEPARTMENT LACERATION KIT-
K802557 · KDD
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 27d
Cleared Nov 12, 1980
TINNITUS RESEARCH AUDIOMETER
K802560 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 27d
Cleared Nov 12, 1980
PRISMA SEAL
K802562 · EBC
Dentsply Intl.
Dental · 27d
Cleared Nov 12, 1980
MEDICAL MAGNETIC TAPE RECORDER
K802564 · DSH
Medical Concepts, Inc.
Cardiovascular · 26d
Cleared Nov 12, 1980
HEMOGLOBIN CONTROL
K802568 · KHG
Marilyn L. Amick
Hematology · 26d
Cleared Nov 12, 1980
ABNORMAL HEMOGLOBIN CONTROL
K802569 · KHG
Marilyn L. Amick
Hematology · 26d
Cleared Nov 12, 1980
BECKMAN LIQUID-STAT LD-L-UV ENZYME
K802572 · CFJ
Beckman Instruments, Inc.
Chemistry · 26d
Cleared Nov 12, 1980
BECKMAN LIQUID STAT LIQUID/ALKALINE PHO
K802574 · CJE
Beckman Instruments, Inc.
Chemistry · 26d
Cleared Nov 12, 1980
EXTERNAL JUGULAR CVP CATHERIZATION KIT
K802576 · DRX
Willson
Cardiovascular · 23d
Cleared Nov 12, 1980
HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY
K802577 · FRG
Associated Medical Products Co.
General Hospital · 23d
Cleared Nov 12, 1980
CYBREX TM FPQ FLUORESCENE POLARIZATION
K802579 · KHO
Abbott Laboratories
Pathology · 23d
Cleared Nov 12, 1980
SUBCLAVIAN CATHETER INSERTION TRAY
K802580 · KXF
American Pharmaseal Div. Ahsc
General Hospital · 28d
Cleared Nov 12, 1980
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY
K802581 · JFJ
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Nov 12, 1980
OTOLOGICAL VENTILATION TUBES
K802587 · ETD
Humboldt Products
Ear, Nose, Throat · 23d
Cleared Nov 12, 1980
MODEL 5460 + 5480 POP-OFF VALVES
K802591 · BSZ
G. Dundas Co.
Anesthesiology · 22d
Cleared Nov 12, 1980
PARAGON SERUM PROTEIN ELECTROPHORESIS
K802592 · CEF
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Nov 12, 1980
BECKMAN DP-5500 DATA REDUCTION SYSTEM
K802594 · JQP
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Nov 12, 1980
ERGO IRRIGATION SYSTEM
K802595 · EFS
Ergo Instruments, Inc.
Dental · 22d
Cleared Nov 12, 1980
TELESONIC, ARCON & SOUNDEX ASP 102
K802596 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d