FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
100921–100944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1995
LOKKI DT
K952682 · GEX
Lokki
General & Plastic Surgery · 155d
Cleared Nov 14, 1995
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
K952898 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 144d
Cleared Nov 14, 1995
THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR
K952901 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 144d
Cleared Nov 14, 1995
THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR
K952902 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 144d
Cleared Nov 14, 1995
THE TULIP COMPANY BRANSON #1 ELEVATOR
K952932 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 141d
Cleared Nov 14, 1995
THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR
K952951 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 141d
Cleared Nov 14, 1995
THE TULIP CXOMPANY BRANSON #2 ELEVATOR
K952953 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 141d
Cleared Nov 14, 1995
THE TULIP COMPANY BRANSON OVERSHEATH
K952958 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 141d
Cleared Nov 14, 1995
PHILIPS EASYVISION
K953095 · LLZ
Philips Medical Systems, Inc.
Radiology · 134d
Cleared Nov 14, 1995
PREMIER EHEC
K953362 · GNA
Meridian Diagnostics, Inc.
Microbiology · 120d
Cleared Nov 14, 1995
EVT-3300
K953621 · INQ
U.S. Table, Inc.
Physical Medicine · 103d
Cleared Nov 14, 1995
ACCESS ALLERGEN DOG EPITHELIM
K953780 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Nov 14, 1995
SHARPLAN LASERS, INC. SURGICAL DIODE LASER
K953794 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 92d
Cleared Nov 14, 1995
ACCESS LOW LEVEL IGE CONTROLS
K953883 · JJX
Bio-Rad Laboratories, Inc.
Immunology · 88d
Cleared Nov 14, 1995
THERATEST LAB, INC., EL-ANASCR KIT
K954106 · LJM
Theratest Laboratories, Inc.
Immunology · 105d
Cleared Nov 14, 1995
BIOFEEDBACK DEVICE
K954127 · HCC
Verimed Holdings, Inc.
Neurology · 75d
Cleared Nov 14, 1995
MED-TEC HAND GRIP
K954225 · IXQ
Medtec, Inc.
Radiology · 64d
Cleared Nov 14, 1995
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
K954355 · LNH
General Electric Co.
Radiology · 57d
Cleared Nov 14, 1995
ENT PACKINGS, WICKS, WIPES, AND SPONGES
K954449 · LYA
Oasis
Ear, Nose, Throat · 81d
Cleared Nov 14, 1995
RETROGRADE KNIFE
K954507 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
RETRACTOR
K954508 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
PROBE KNIFE
K954509 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
RRIANGLE KNIFE
K954510 · HRX
Phx Technologies Corp.
Orthopedic · 47d
Cleared Nov 14, 1995
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
K954734 · FET
The Tulip Mfg. Co.
Gastroenterology & Urology · 42d