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
147673–147696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 1985
GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP
K852357 · HFB
Gyneco, Inc.
Obstetrics & Gynecology · 32d
Cleared Jul 05, 1985
SYRINGE INFUSION PUMP - AS 20 SERIES
K852358 · FRN
Baxter Healthcare Corp
General Hospital · 32d
Cleared Jul 05, 1985
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373 · GKH
Abbott Diagnostics
Hematology · 31d
Cleared Jul 05, 1985
MODEL 500 PEDIATRIC STRETCHER/CRIB
K852422 · FMS
Midmark Corp.
General Hospital · 28d
Cleared Jul 05, 1985
ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION
K852507 · LLO
Endo Lase, Inc.
Anesthesiology · 23d
Cleared Jul 05, 1985
MODIFICATION FETAL MONITOR MODEL FM-2
K852518 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 23d
Cleared Jul 03, 1985
OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO
K851647 · FGE
Meadox Surgimed, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 03, 1985
THE SUNTANNING CO. TANNING BED
K852579 · FTC
The Suntanning Company, Inc.
General & Plastic Surgery · 15d
Cleared Jul 02, 1985
CORDIA S4 -TREPONEMA PALLIDUM
K850329 · LIP
Cordis Corp.
Immunology · 155d
Cleared Jul 02, 1985
COMPLETE DENTURE REPAIR KIT
K850927 · EBO
Tooth Aid Lab, Inc.
Dental · 119d
Cleared Jul 02, 1985
AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200
K851251 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 97d
Cleared Jul 02, 1985
DIALYSIS CONCENTRATE
K851319
Ries Biologicals
Gastroenterology & Urology · 91d
Cleared Jul 02, 1985
PRECISION HARVEST & INLAY INSTRUMENT SET
K851339 · HWK
Concept, Inc.
Orthopedic · 90d
Cleared Jul 02, 1985
POWER DRIVE WHEELCHAIR-VARIOUS
K851381 · ITI
Everest & Jennings, Inc.
Physical Medicine · 85d
Cleared Jul 02, 1985
SONICATOR 705 MODEL ME 705
K851397 · IMI
Mettler Electronics Corp.
Physical Medicine · 84d
Cleared Jul 02, 1985
UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER
K851684 · KOD
Urotec Systems Corp.
Gastroenterology & Urology · 70d
Cleared Jul 02, 1985
930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES
K851718 · EMK
Artiberia
Dental · 68d
Cleared Jul 02, 1985
1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS
K851719 · EZZ
Artiberia
Gastroenterology & Urology · 68d
Cleared Jul 02, 1985
1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS
K851720 · EGN
Artiberia
Dental · 68d
Cleared Jul 02, 1985
1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS
K851721 · EMN
Artiberia
Dental · 68d
Cleared Jul 02, 1985
1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS
K851722 · EKC
Artiberia
Dental · 68d
Cleared Jul 02, 1985
1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS
K851723 · EKD
Artiberia
Dental · 68d
Cleared Jul 02, 1985
1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS
K851724 · EKB
Artiberia
Dental · 68d
Cleared Jul 02, 1985
1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN
K851726 · EIY
Artiberia
Dental · 68d