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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
147985–148008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1985
MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA
K851329 · JLW
Corning Medical & Scientific
Chemistry · 70d
Cleared Jun 13, 1985
1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE
K851748 · GWZ
Artiberia
Neurology · 49d
Cleared Jun 13, 1985
1-380 PINWHEEL (WARTENBERG)
K851749 · GWY
Artiberia
Neurology · 49d
Cleared Jun 13, 1985
ORTHOPEADIC CEMENT DELIVERY SYSTEM
K851881 · KIH
Dentsply Intl.
Orthopedic · 45d
Cleared Jun 13, 1985
VPDS-1 VENNES PANCREATIC DILATION SET
K851956 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 13, 1985
E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE
K851964 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 13, 1985
SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL
K852070 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 34d
Cleared Jun 13, 1985
ALBA DRY BURN PAD
K852091 · NAD
Alba-Waldensian, Inc.
General & Plastic Surgery · 31d
Cleared Jun 13, 1985
WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
K852138 · IAF
Canyon Diagnostics, Inc.
Pathology · 28d
Cleared Jun 13, 1985
STERILE SURGICAL BLADES
K852141 · GES
Miltex Instrument Co.
General & Plastic Surgery · 28d
Cleared Jun 12, 1985
MFE CARDIAC STRESS SYSTEM
K850868
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
MFE COUCH ERGOMETER
K850869 · ISD
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
MEDIFETTE ERGOMETER
K850870
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL
K850873 · INO
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR
K850877 · ILK
Ketronic, Inc.
Physical Medicine · 103d
Cleared Jun 12, 1985
AGGRO/LINK COMPUTER INTERFACE
K851025 · JBX
Chrono-Log Corp.
Hematology · 93d
Cleared Jun 12, 1985
COBE SYSTEM 3
K851306 · FKP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 72d
Cleared Jun 12, 1985
STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
K851362 · FKH
Rna Medical Corp.
Gastroenterology & Urology · 69d
Cleared Jun 12, 1985
HEMODIALYSIS CONCENTRATE ADDITIVES
K851431 · KPO
Dana Laboratories
Gastroenterology & Urology · 63d
Cleared Jun 12, 1985
VALTRAC PURSESTING DEVICE
K851452 · HCF
Davis & Geck, Inc.
General & Plastic Surgery · 62d
Cleared Jun 12, 1985
BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR
K851470 · KNX
Lic-Orthion
Gastroenterology & Urology · 58d
Cleared Jun 12, 1985
TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR
K851471 · KNX
Lic-Orthion
Gastroenterology & Urology · 58d
Cleared Jun 12, 1985
CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO
K851539 · KNT
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 57d
Cleared Jun 12, 1985
PREFER INCONTINENCE AID
K851876 · EYQ
Rocky Mountain Medical Corp.
Gastroenterology & Urology · 44d