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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112585–112608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1993
SILICONE TYMPANOSTOMY TUBES
K932166 · ETD
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 83d
Cleared Jul 26, 1993
FUJI EC ID CAMERA
K932357 · JAC
Fujifilm Medical System U.S.A., Inc.
Radiology · 73d
Cleared Jul 26, 1993
FUJIFILM EC-B SERIES CASETTE
K932565 · IXA
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Jul 26, 1993
CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL
K932662 · LAS
More Diagnostics
Toxicology · 54d
Cleared Jul 26, 1993
GXP DENTAL X-RAY PROCESSOR
K932675 · EGN
Gendex Corp.
Radiology · 54d
Cleared Jul 26, 1993
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988 · EOB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 38d
Cleared Jul 26, 1993
MODEL 5030 SUCTION HANDPIECE SYSTEM
K933017 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 35d
Cleared Jul 26, 1993
351-AGCO BEHIND-THE-EAR HEARING AID
K933095 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 32d
Cleared Jul 23, 1993
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
K921182 · JWH
Biomet, Inc.
Orthopedic · 500d
Cleared Jul 23, 1993
ADVANTAGE
K921547 · FMT
Kci
General Hospital · 486d
Cleared Jul 23, 1993
STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV
K923589 · LYY
Tomarc (M) Sdn Bhd
General Hospital · 368d
Cleared Jul 23, 1993
REFLEX(R) ESP
K924881 · GEI
Richard-Allan Medical
General & Plastic Surgery · 298d
Cleared Jul 23, 1993
CATALOG NUMBER 111 (FACESHIELD)
K925290 · LYU
Ansley Medical Products, Inc.
General Hospital · 275d
Cleared Jul 23, 1993
IMS-200
K925670 · JOY
Intelligent Medica Imaging, Inc.
Hematology · 255d
Cleared Jul 23, 1993
KENSEY NASH WUIK-SERT(TM) ENDOSCOPIC SURG GRASPER
K926089 · GCJ
Kensey Nash Corp.
General & Plastic Surgery · 233d
Cleared Jul 23, 1993
DTX-100
K926300 · KGI
Hologic, Inc.
Radiology · 221d
Cleared Jul 23, 1993
NEEDLE, PNEUMOPERITONEUM, SPRING LOADED
K930474 · FHO
Ranfac, Corp.
Gastroenterology & Urology · 176d
Cleared Jul 23, 1993
SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES
K930512 · GAZ
Core Dynamics, Inc.
General Hospital · 172d
Cleared Jul 23, 1993
NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM II PUMP
K930572 · GCJ
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 169d
Cleared Jul 23, 1993
LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION
K930716 · GCJ
Gabris Surgical Corp.
General & Plastic Surgery · 162d
Cleared Jul 23, 1993
URETERAL STENT
K930733 · FAD
Surgitek
Gastroenterology & Urology · 162d
Cleared Jul 23, 1993
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K931278 · GCJ
Interventional Therapeutics Corp.
General & Plastic Surgery · 137d
Cleared Jul 23, 1993
MICRO ENDOSCOPIC ELECTRODE (ME2)
K931281 · GCJ
Codman & Shurtleff, Inc.
General & Plastic Surgery · 136d
Cleared Jul 23, 1993
ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT
K931306 · GEX
Cardiogenes
General & Plastic Surgery · 130d