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
119953–119976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1991
CODMAN SKULL CLAMP
K913170 · HBL
Codman & Shurtleff, Inc.
Neurology · 51d
Cleared Sep 06, 1991
ENDOSCOPIC DELIVERY SYSTEM
K913172 · GCJ
Medco Products, Co., Inc.
General & Plastic Surgery · 51d
Cleared Sep 06, 1991
ULTRACROWN(TM) PD DENTAL ALLOY
K913232 · EJS
Dentsply Intl.
Dental · 46d
Cleared Sep 06, 1991
DIGITOXIN (FPIA) KIT
K913240 · LFM
Tudor Laboratories, Inc.
Toxicology · 46d
Cleared Sep 06, 1991
DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING
K913411 · GDW
Davis & Geck, Inc.
General & Plastic Surgery · 37d
Cleared Sep 06, 1991
HEART TECHNOLOGY ROTABLATOR WIRECLIP
K913450 · MCW
Heart Technology, Inc.
Cardiovascular · 35d
Cleared Sep 06, 1991
E-Z CLEAN ELECTRODE
K913473 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 32d
Cleared Sep 06, 1991
VORTECH'S PERSONAL DISPLAY SYSTEM
K913491 · JAK
Vortech Data, Inc.
Radiology · 31d
Cleared Sep 06, 1991
PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT
K913502 · ESD
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 06, 1991
PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT
K913503 · ESD
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 06, 1991
GAUZE PACKING, SURGICAL STERILE AND NON-STERILE
K913575 · FRO
Keilei Intl., Inc.
General & Plastic Surgery · 25d
Cleared Sep 06, 1991
DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL
K913650 · DIF
Duo Research, Inc.
Chemistry · 21d
Cleared Sep 05, 1991
WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)
K901619 · LOS
Wex Medical Instrumentation Co.
Cardiovascular · 517d
Cleared Sep 05, 1991
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · KWQ
Acromed Corp.
Orthopedic · 342d
Cleared Sep 05, 1991
HD-4 CROWN & BRIDGE ALLOY
K905034 · EJH
Ho Dental Co., Inc.
Dental · 302d
Cleared Sep 05, 1991
CRYPTOSPORIDIUM ANTIGEN DETECTION
K905598 · MHJ
Lmd Laboratories
Microbiology · 266d
Cleared Sep 05, 1991
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST
K911457 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 155d
Cleared Sep 05, 1991
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
K911625 · LCP
Heraeus Kulzer, Inc.
Hematology · 147d
Cleared Sep 05, 1991
WILSON-COOK RUSSELL GASTROSTOMY KIT
K912047 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Sep 05, 1991
GS-220 HAND IMPAIRMENT EVALUATION SYSTEM
K912526 · LBB
J-Tech, Inc.
Neurology · 90d
Cleared Sep 05, 1991
CARDIOCAP II(TM)
K912530 · DXN
Datex Medical Instrumentation, Inc.
Cardiovascular · 90d
Cleared Sep 05, 1991
MEGA PERICARDIOCENTESIS KIT
K912564 · DQY
Mega Medical, Inc.
Cardiovascular · 86d
Cleared Sep 05, 1991
MASTERPIECES(TM)/MICRO/MINI SYSTEMS
K913289 · HRS
Storz Instrument Co.
Orthopedic · 43d
Cleared Sep 05, 1991
ARMREST
K913507 · KNN
Pin Dot Products, Inc.
Physical Medicine · 29d