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
142177–142200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1986
SWIVEL COUPLER
K863205 · BYJ
Venmill Swivel, Co.
Anesthesiology · 44d
Cleared Oct 02, 1986
CREATININE PROCEDURE
K863261 · CGX
Data Medical Associates, Inc.
Chemistry · 38d
Cleared Oct 02, 1986
DISPOSABLE PNEUMOPERITONEUM NEEDLE
K863330 · FHO
United States Surgical, A Division of...
Gastroenterology & Urology · 44d
Cleared Oct 02, 1986
MODEL MC-1 SURGICAL VIDEO CAMERA
K863376 · FWF
Biometric Products, Inc.
General & Plastic Surgery · 29d
Cleared Oct 02, 1986
BIPOL CABLE
K863412 · GEI
Treace Medical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 02, 1986
BIPOLFORCEPS
K863413 · GEI
Treace Medical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 02, 1986
TAMPAX SUPER TAMPONS
K863464 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 24d
Cleared Oct 02, 1986
COLORADO MEDICAL MODEL PTC 1000
K863471 · KXM
Colorado Medical, Inc.
Gastroenterology & Urology · 23d
Cleared Oct 02, 1986
WEINGART MODEL 1000 SUNLAMP PRODUCT
K863518 · FTC
Weingart, Inc.
General & Plastic Surgery · 23d
Cleared Oct 02, 1986
POTASSIUM HYDROXIDE 10% W/V
K863550 · PPM
Reagent Laboratory, Inc.
Chemistry · 20d
Cleared Oct 02, 1986
BREMI BEAUTY BRONZE
K863555 · FTC
Handelsonderneming Bremi B.V.
General & Plastic Surgery · 20d
Cleared Oct 02, 1986
URESIL RADIOPAQUE SILICONE BANDS
K863563
Uresil Corp.
General & Plastic Surgery · 20d
Cleared Oct 02, 1986
VIDEO CAMERA SYSTEM
K863598 · FWF
American Edwards Laboratories
General & Plastic Surgery · 17d
Cleared Oct 02, 1986
MICRO SURGICAL DRILL SYSTEM
K863627
Acumed Instruments Corp.
General & Plastic Surgery · 15d
Cleared Oct 02, 1986
GENTEEL
K863676 · ELC
Luben Dental Co., Inc.
Dental · 13d
Cleared Oct 02, 1986
MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K863697 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 10d
Cleared Oct 01, 1986
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON
K860638 · DSP
Kontron Instruments, Inc.
Cardiovascular · 223d
Cleared Oct 01, 1986
TRACKER INFUSION CATHETER
K862117 · DQY
Target Therapeutics
Cardiovascular · 120d
Cleared Oct 01, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K862705 · GQI
Labsystems, Inc.
Microbiology · 77d
Cleared Oct 01, 1986
STOCKERT-SHILEY CAPS TIMER MODULE
K862973 · DTQ
Shiley, Inc.
Cardiovascular · 56d
Cleared Oct 01, 1986
EUROFLEX F-IV, ISOFLEX III
K863007
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
MINILAX SET
K863012
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
ISOLAX PEDAL SET
K863013
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
ISOPRAT F-III SET/ISOLAX CHAIR
K863014
Sds Dental, Inc.
Dental · 54d