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
109081–109104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1994
AURIUM C
K940789 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared Mar 29, 1994
AURIUM G13 (HIGH GOLD CROWN AND BRIDGE ALLOY)
K940856 · EJT
Argen Precious Metals, Inc.
Dental · 34d
Cleared Mar 28, 1994
BRYAN SPINAL FIXATER (BSF)
K914548 · KWP
Arcan Orthopaedic Corp.
Orthopedic · 899d
Cleared Mar 28, 1994
ELECTRONIC INSUFFLATOR MODEL 2054.61
K921756 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 714d
Cleared Mar 28, 1994
ABBOTT SMART CAP
K921818 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 712d
Cleared Mar 28, 1994
LUXTRON MODEL 3100/3101/3102 MULTICHANNEL
K923189 · FLL
Luxtron
General Hospital · 636d
Cleared Mar 28, 1994
QUICKIE P200
K924278 · ITI
Quickie Designs, Inc.
Physical Medicine · 580d
Cleared Mar 28, 1994
ELECTRIC MOBILITY RASCAL
K924515 · INI
Electric Mobility Corp.
Physical Medicine · 570d
Cleared Mar 28, 1994
KID POWER
K925865 · ITI
Everest & Jennings, Inc.
Physical Medicine · 494d
Cleared Mar 28, 1994
LEGEND SC 300
K926295 · INI
Pride Health Care, Inc.
Physical Medicine · 469d
Cleared Mar 28, 1994
CELEBRITY SC400
K926296 · INI
Pride Health Care, Inc.
Physical Medicine · 469d
Cleared Mar 28, 1994
SHUTTLE SC-140
K926499 · INI
Pride Health Care, Inc.
Physical Medicine · 454d
Cleared Mar 28, 1994
FORTRESS C-500 MICROPROCESSOR CONTROLLER
K930088 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 445d
Cleared Mar 28, 1994
ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
K930129 · LJS
Arrow Intl., Inc.
General Hospital · 440d
Cleared Mar 28, 1994
PRIDE LEGEND SC-340
K930952 · INI
Pride Health Care, Inc.
Physical Medicine · 398d
Cleared Mar 28, 1994
CELEBRITY SC440
K930953 · INI
Pride Health Care, Inc.
Physical Medicine · 398d
Cleared Mar 28, 1994
LOGYK ACETABULAR COMPONENT SYSTEM
K931107 · MBL
Arthronics, Inc.
Orthopedic · 390d
Cleared Mar 28, 1994
IL TEST(TM) TRIGLYCERIDE
K931116 · JGY
Instrumentation Laboratory CO
Toxicology · 389d
Cleared Mar 28, 1994
LOW PROFILE SLEAVE NUT ASSEMBLY
K931208 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 383d
Cleared Mar 28, 1994
HAND-TROL S
K931215 · DWG
Aspen Labs
General & Plastic Surgery · 383d
Cleared Mar 28, 1994
LINK CERAMIC HEADS 14/16 X 32MM
K931572 · LZO
Link America, Inc.
Orthopedic · 363d
Cleared Mar 28, 1994
FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER
K931636 · ISA
Fairform Mfg., Co., Ltd.
Physical Medicine · 362d
Cleared Mar 28, 1994
A013 FEMI-FORM FACIAL MASSAGER
K931637 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 362d
Cleared Mar 28, 1994
FO96 HANDY MASSAGER
K931638 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 362d