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
171985–172008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1978
FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
K772345 · DCB
Kallestad Laboratories, Inc.
Microbiology · 13d
Cleared Jan 05, 1978
PREGNANCY TEST KIT, ANSWER
K772359 · LCX
Diagnostic Testing, Inc.
Chemistry · 9d
Cleared Jan 05, 1978
AUTO. SAMPLING SYSTEM
K772364 · KIE
Hewlett-Packard Co.
Toxicology · 9d
Cleared Jan 05, 1978
LAP BOARD W/RIM
K772401 · IMX
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jan 05, 1978
RESTING PAN SPLINTS
K772410 · ILH
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jan 05, 1978
PLATFORM SPLINTS
K772411 · ILH
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jan 05, 1978
PINCH GUAGE
K772413 · HRW
Fred Sammons, Inc.
Neurology · 9d
Cleared Jan 05, 1978
DYNAMETER 50 LB.
K772415 · HRW
Fred Sammons, Inc.
Neurology · 9d
Cleared Jan 05, 1978
PRE-FORMED SPLINT BLANKS
K772416 · ILH
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jan 05, 1978
SLIDING BOARD
K772417 · IKX
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jan 05, 1978
REAR FASTENING SAFETY STRAP
K772420 · IQB
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jan 05, 1978
WHEELCHAIR BELT
K772421 · IQB
Fred Sammons, Inc.
Physical Medicine · 9d
Cleared Jan 05, 1978
RIANEN GENTAMICIN RIA KIT
K772425 · DJB
New England Nuclear
Immunology · 7d
Cleared Jan 04, 1978
NEUTROCIM
K771114 · EMA
Septodont, Inc.
Dental · 197d
Cleared Jan 04, 1978
XYREL-RA MODELS 5994/5995
K771770 · DXY
Medtronic Vascular
Cardiovascular · 107d
Cleared Jan 04, 1978
CARDIAC PULSE GENERATORS 5982/5983
K771786 · DXY
Medtronic Vascular
Cardiovascular · 105d
Cleared Jan 03, 1978
PATIENT BY-PASS
K771422 · FJQ
Quinton, Inc.
Gastroenterology & Urology · 155d
Cleared Jan 03, 1978
A-V SHUNT EXTENSION
K771425 · FKN
Quinton, Inc.
Gastroenterology & Urology · 155d
Cleared Jan 03, 1978
RINSE BLOCK CONNECTOR
K771482 · KDJ
Quinton, Inc.
Gastroenterology & Urology · 152d
Cleared Jan 03, 1978
TINNITUS MASKERS, MODELS S564&S574
K771769 · KLW
Vicon Instrument Co.
Ear, Nose, Throat · 106d
Cleared Jan 03, 1978
5UM FILTERSET WITH Y-INJECTION SITE
K771972 · FPB
Abbott Laboratories
General Hospital · 78d
Cleared Jan 03, 1978
CARDIAC OUTPUT COMPUTER MODEL 701
K771977 · DSK
Instrumentation Laboratory CO
Cardiovascular · 78d
Cleared Jan 03, 1978
SCALP VEIN SETS
K772008 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 75d
Cleared Jan 03, 1978
CATHETER, INTRACRANIAL PRESS. MONITOR.
K772063 · GWM
Cordis Corp.
Neurology · 62d