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
90145–90168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1998
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
K974067 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 123d
Cleared Feb 27, 1998
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER...
K974082 · LKY
Performance Plus, Inc.
Gastroenterology & Urology · 121d
Cleared Feb 27, 1998
EPS
K974504 · LLZ
E For M Imaging Systems Div.,...
Radiology · 88d
Cleared Feb 27, 1998
LSF HA COATED TRIAD TOTAL HIP SYSTEM
K974506 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Feb 27, 1998
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
K974556 · JWH
Osteonics Corp.
Orthopedic · 84d
Cleared Feb 27, 1998
PERITONEAL DIALYSIS CATHETER CONNECTOR
K974570 · FKO
Medigroup, Inc.
Gastroenterology & Urology · 81d
Cleared Feb 27, 1998
3.25MM SIMPLER THREADED DENTAL IMPLANT
K974856 · DZE
Vancouver Implant Resources, Inc.
Dental · 60d
Cleared Feb 27, 1998
4.0MM SIMPLER THREADED DENTAL IMPLANT
K974857 · DZE
Vancouver Implant Resources, Inc.
Dental · 60d
Cleared Feb 27, 1998
CYNOSURE PHOTOGENICA 532 LASER
K974900 · GEX
Cynosure, Inc.
General & Plastic Surgery · 59d
Cleared Feb 27, 1998
MENTOR SKIN PROTECTION PAD
K980050 · GCJ
Mentor Corp.
General & Plastic Surgery · 52d
Cleared Feb 27, 1998
SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
K980156 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 42d
Cleared Feb 27, 1998
DERMASENSE PLUS DISPERSIVE ELECTRODE
K980171 · GEI
Horizon Medical, Inc.
General & Plastic Surgery · 38d
Cleared Feb 27, 1998
MSB TENS ELECTRODES (DISPOSABLE)
K980229 · GXY
Msb , Ltd.
Neurology · 36d
Cleared Feb 27, 1998
WELCH ALLYN XENON 300 LIGHT SOURCE
K980281 · GCT
Welch Allyn, Inc.
Gastroenterology & Urology · 32d
Cleared Feb 27, 1998
AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240
K980366 · GEI
Aaron Medical Industries
General & Plastic Surgery · 29d
Cleared Feb 27, 1998
BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT...
K980418 · LPL
Benz Research and Development Corp.
Ophthalmic · 24d
Cleared Feb 26, 1998
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
K971592 · ILJ
The Silcraft Corp.
Physical Medicine · 301d
Cleared Feb 26, 1998
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT...
K971593 · ILJ
The Silcraft Corp.
Physical Medicine · 301d
Cleared Feb 26, 1998
ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
K972877 · FMF
Safety Syringes, Inc.
General Hospital · 206d
Cleared Feb 26, 1998
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972883 · FXX
Cypress Medical Products, Ltd.
General Hospital · 205d
Cleared Feb 26, 1998
ULTRASAFE MODEL T200 INJECTOR
K972900 · FMF
Safety Syringes, Inc.
General Hospital · 204d
Cleared Feb 26, 1998
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
K973000 · MSQ
Alimenterics, Inc.
Microbiology · 198d
Cleared Feb 26, 1998
PREVENT I
K973373 · INO
The Buzzz Corp.
Physical Medicine · 171d
Cleared Feb 26, 1998
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT...
K974492 · MLD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d