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

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175,820 results
124129–124152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1990
STOMACH, GASTRO-ENTEROSTOMY
K902421 · KDH
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 173d
Cleared Nov 20, 1990
HEMODIALYSIS SYSTEM AND ACCESSORY
K902426 · FJK
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 173d
Cleared Nov 20, 1990
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
K902526 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 168d
Cleared Nov 20, 1990
MICROETCHER
K902836 · KOJ
Danville Engineering, Inc.
Dental · 145d
Cleared Nov 20, 1990
DEVICE PART NUMBER: SVD-3S DRILL
K902930 · DZE
Minimatic Implant Technology
Dental · 138d
Cleared Nov 20, 1990
TC-1111 TRANSFER PIN
K903044 · DZE
Minimatic Implant Technology
Dental · 132d
Cleared Nov 20, 1990
FREEVENT (TM)
K903057 · BYD
Pharma Systems, Inc.
Anesthesiology · 132d
Cleared Nov 20, 1990
TUBE GASTROSTOMY
K903086 · KGC
Knight Medical, Inc.
Gastroenterology & Urology · 131d
Cleared Nov 20, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30
K903318 · LNH
Summit World Trade Corp.
Radiology · 118d
Cleared Nov 20, 1990
KETONE TEST B SANWA STANDARD
K903366 · JIN
Ihara Medics U.S., Inc.
Chemistry · 117d
Cleared Nov 20, 1990
KETONE TEST A SANWA STANDARD
K903367 · JIN
Ihara Medics U.S., Inc.
Chemistry · 117d
Cleared Nov 20, 1990
ABO-1122 ANALOG BALL OVERDENTURE
K903518 · DZE
Minimatic Implant Technology
Dental · 109d
Cleared Nov 20, 1990
MAGNETIC RESONANCE DEVICE MRT 150A
K903768 · LNH
Toshiba America Mri, Inc.
Radiology · 92d
Cleared Nov 20, 1990
MRT 50A
K903770 · LNH
Toshiba America Mri, Inc.
Radiology · 92d
Cleared Nov 20, 1990
90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET
K903869 · KDJ
Fresenius/Delmed, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 20, 1990
OSTEONICS SR GLENOID COMPONENTS
K903886 · KWS
Osteonics Reconstructive Products Div.
Orthopedic · 90d
Cleared Nov 20, 1990
EXEL A-V FISTULA SET
K903945 · FIE
Exel Intl.
Gastroenterology & Urology · 85d
Cleared Nov 20, 1990
SEP 90
K904103 · IZP
Elema-Schonander, Inc.
Radiology · 75d
Cleared Nov 20, 1990
PROSTHETIC CEMENT REMOVER
K904180 · LZV
Origin Medsystems, Inc.
Orthopedic · 70d
Cleared Nov 20, 1990
ADVANCED C- SPINE COIL
K904327 · LNH
Toshiba America Mri, Inc.
Radiology · 61d
Cleared Nov 20, 1990
SATC-1114, SHOULDER ABUTMENT TRANSFER COPING
K904460 · DZE
Minimatic Implant Technology
Dental · 50d
Cleared Nov 20, 1990
INSTRUMENTARIUM MEGA4, MODIFICATION
K904528 · LNH
Instrumentarium Imaging, Inc.
Radiology · 50d
Cleared Nov 20, 1990
LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS
K904541 · LDJ
Abbott Laboratories
Toxicology · 47d
Cleared Nov 20, 1990
CIBA CORNING ACS FSH IMMUNOASSAY
K904649 · CGJ
Ciba Corning Diagnostics Corp.
Chemistry · 40d