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
114985–115008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1992
MODEL 4280 SURGICAL EXTENSION CABLE
K922899 · DSA
Pace Medical
Cardiovascular · 190d
Cleared Dec 23, 1992
ZENON PLUS
K922955 · EJS
Jeneric/Pentron, Inc.
Dental · 188d
Cleared Dec 23, 1992
ENCORE DS-DNA
K923537 · LRM
Clark Laboratories, Inc.
Immunology · 160d
Cleared Dec 23, 1992
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K923601 · FRN
Abbott Laboratories
General Hospital · 176d
Cleared Dec 23, 1992
STACLOT LA TEST KIT
K923731 · GFO
American Bioproducts Co.
Hematology · 149d
Cleared Dec 23, 1992
.016' X .016 NICKEL TITANIUM UPRIGHTING SPRING
K923836 · DZC
Ultimate Wireforms, Inc.
Dental · 146d
Cleared Dec 23, 1992
QUIKSEAL
K923895 · EBC
Mirage Dental Systems
Dental · 141d
Cleared Dec 23, 1992
INFINITY MICRO IRRIGATOR
K924052 · KYG
Infinity Surgical Technology, Inc.
Ophthalmic · 133d
Cleared Dec 23, 1992
LPIA-FERRITIN ASSAY
K924186 · DEF
Seradyn, Inc.
Immunology · 125d
Cleared Dec 23, 1992
AMO ELITE
K924235 · HQC
Allergan Medical Optics
Ophthalmic · 121d
Cleared Dec 23, 1992
UNI-CHECK REAGENT STRIP
K924398 · CGA
Diagnostic Solutions, Inc.
Chemistry · 114d
Cleared Dec 23, 1992
RED DOT 2515 CARDIAC SENSOR SYSTEM
K924487 · BRX
3M Health Care, Ltd.
Anesthesiology · 111d
Cleared Dec 23, 1992
3M VITREMER TRI-CURE GLASS IONOMER SYSTEM
K925032 · EMA
3M Company
Dental · 79d
Cleared Dec 23, 1992
MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS
K925495 · LQR
Boston Scientific Corp
Gastroenterology & Urology · 51d
Cleared Dec 23, 1992
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702 · MSJ
Nichols Institute Diagnostics
Immunology · 41d
Cleared Dec 23, 1992
HELI-TECH RETRIEVAL BASKET
K926040 · LQR
Cape Tech Medical Products
Gastroenterology & Urology · 22d
Cleared Dec 21, 1992
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
K920891 · DQX
Cook, Inc.
Cardiovascular · 301d
Cleared Dec 21, 1992
HANDPIECE MODELS MS-350, RS-350
K922437 · EFB
Dabi-Atlante America Corp.
Dental · 213d
Cleared Dec 21, 1992
NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
K922674 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 200d
Cleared Dec 21, 1992
PM2002 PROLINE, PM2002 PROLINE EC
K923461 · KLC
Planmeca USA, Inc.
Dental · 160d
Cleared Dec 21, 1992
DELIGHT
K923462 · EAZ
Planmeca USA, Inc.
Dental · 160d
Cleared Dec 21, 1992
CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS
K923646 · GWG
Codman & Shurtleff, Inc.
Neurology · 153d
Cleared Dec 21, 1992
SUPPLE PERI-GUARD
K923657 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 208d
Cleared Dec 21, 1992
DIAGNOSTIC INTRAVASCULAR CATHETER
K923699 · DQO
Applied Vascular
Cardiovascular · 150d