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
125065–125088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1990
WILSON-COOK BILIARY MOTILITY CATHETER
K900058 · FFX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 205d
Cleared Jul 27, 1990
MODEL #M8 ELECTRONIC STERILIZER
K900432 · FLE
Midmark Corp.
General Hospital · 178d
Cleared Jul 27, 1990
IMX CMV IGM ANTIBODY ASSAY
K900473 · LFZ
Abbott Laboratories
Microbiology · 176d
Cleared Jul 27, 1990
IMX CMV IGG ANTIBODY ASSAY
K900474 · LFZ
Abbott Laboratories
Microbiology · 176d
Cleared Jul 27, 1990
INTERPORE IMZ SINGLE TOOTH ATTACHMENT SYSTEM
K900793 · DZE
Interpore Intl.
Dental · 157d
Cleared Jul 27, 1990
OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION
K900877 · HQY
Sunglass Originals, Inc.
Ophthalmic · 151d
Cleared Jul 27, 1990
REXTON RX12 POWER PLUS W/DUAL RECEIVER
K901341 · ESD
Rexton, Inc.
Ear, Nose, Throat · 127d
Cleared Jul 27, 1990
TRANSDUCER PROTECTOR
K901409 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 123d
Cleared Jul 27, 1990
GC-1000 THROUGH GC-3005 ACID CONCENTRATE
K901471 · KPO
Granite Chemical Co., Inc.
Gastroenterology & Urology · 121d
Cleared Jul 27, 1990
GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS
K901472 · KPO
Granite Chemical Co., Inc.
Gastroenterology & Urology · 121d
Cleared Jul 27, 1990
GC-01 THROUGH GC-99 ACETATE CONCENTRATE
K901473 · KPO
Granite Chemical Co., Inc.
Gastroenterology & Urology · 121d
Cleared Jul 27, 1990
DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
K901477 · FKX
Delmed, Inc.
Gastroenterology & Urology · 122d
Cleared Jul 27, 1990
DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
K901478 · FKX
Delmed, Inc.
Gastroenterology & Urology · 122d
Cleared Jul 27, 1990
QUIDEL CHLAMYDIA TEST
K901660 · LJC
Quidel Corp.
Microbiology · 108d
Cleared Jul 27, 1990
BIOCHEM 9100 MULTIGAS MONITOR
K901861 · CCK
Biochem International, Inc.
Anesthesiology · 93d
Cleared Jul 27, 1990
URESIL ENDOSCOPIC LASER OVERTUBE
K901882 · KOQ
Uresil Corp.
Dental · 92d
Cleared Jul 27, 1990
DITER ULTRASONIC S 3000
K901950 · IMI
Diter Elektroniikka OY
Physical Medicine · 87d
Cleared Jul 27, 1990
RAREX & OPTEX X-RAY SCREENS
K902039 · EAM
Mci Optonix, Inc.
Radiology · 84d
Cleared Jul 27, 1990
T19S BIOPSY NEEDLE
K902077 · KNW
Ohio Medical Instrument Co., Inc.
Gastroenterology & Urology · 80d
Cleared Jul 27, 1990
MODEL TR RECTAL SUCTION BIOPSY TUBE
K902097 · FCK
Medical Measurements, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 27, 1990
PERITONEAL CATHETERS
K902101 · FJS
Akcess Medical Products, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 27, 1990
PALAPRESS(R) VARIO RESIN
K902115 · EBI
Kulzer, Inc.
Dental · 78d
Cleared Jul 27, 1990
LAKE GASTROSTOMY TUBE
K902121 · KGC
Lake Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jul 27, 1990
ESCORT MODEL 400T TELEMETRY ECG MONITOR
K902254 · DXH
Medical Data Electronics
Cardiovascular · 67d