FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cleared only ×
175,230 results
42745–42768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2012
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX...
K120924 · LPH
Corentec Co., Ltd.
Orthopedic · 167d
Cleared Sep 10, 2012
VISIONS PV .035 DITITAL IVUS CATHETER
K121273 · OBJ
Volcano Corporation
Cardiovascular · 136d
Cleared Sep 10, 2012
LANX SPINAL FIZATION SYSTEM
K121316 · NKB
Lanx, Inc.
Orthopedic · 131d
Cleared Sep 10, 2012
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K121372 · DXN
Andon Health Co, Ltd.
Cardiovascular · 126d
Cleared Sep 10, 2012
INTEGRA CAMINO ICP MONITOR
K121573 · GWM
Intrgra Lifesciences Corporation
Neurology · 104d
Cleared Sep 10, 2012
DELICOT
K121822 · HBA
American Surgical Company, LLC
Neurology · 81d
Cleared Sep 10, 2012
EARLYSENSE CENTRAL DISPLAY SYSTEM
K121885 · MSX
Earlysense, Ltd.
Cardiovascular · 74d
Cleared Sep 10, 2012
TAPERSET HIP SMALL STEMS
K121935 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 70d
Cleared Sep 10, 2012
ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
K121947 · LZA
Northstar Healthcare Holdings
General Hospital · 69d
Cleared Sep 10, 2012
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K122363 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 35d
Cleared Sep 10, 2012
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3...
K122498 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 25d
Cleared Sep 10, 2012
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX
K122612 · MAL
Maquet Cardiovascular, LLC
Cardiovascular · 14d
Cleared Sep 07, 2012
SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS
K113407 · GEI
Carefusion 2200, Inc.
General & Plastic Surgery · 294d
Cleared Sep 07, 2012
INFRARED THERMOMETER
K113761 · FLL
Famidoc Technology Co., Ltd.
General Hospital · 261d
Cleared Sep 07, 2012
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K113821 · DXG
Transonic Systems, Inc.
Cardiovascular · 255d
Cleared Sep 07, 2012
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
K120609 · LBS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 191d
Cleared Sep 07, 2012
ZYNO MEDICAL ADMINISTRATION SET
K120685 · FPA
Zyno Medical, LLC
General Hospital · 185d
Cleared Sep 07, 2012
B&W DENTAL IMPLANT SYSTEM
K120875 · DZE
B&W Srl
Dental · 169d
Cleared Sep 07, 2012
PONTO BONE ANCHORED HEARING SYSTEM
K121228 · MAH
Oticon Medical AB
Ear, Nose, Throat · 137d
Cleared Sep 07, 2012
MINI PATCH
K121353 · NUH
Well-Life Healthcare Limited
Neurology · 126d
Cleared Sep 07, 2012
HEMOCUE HBA1C 501
K121366 · LCP
Infopia Co, Ltd.
Chemistry · 123d
Cleared Sep 07, 2012
MINIARC PRO SINGLE-INCISION SLING SYSTEM
K121641 · PAH
American Medical Systems
Gastroenterology & Urology · 95d
Cleared Sep 07, 2012
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · HSD
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Sep 07, 2012
VERACIA
K121749 · ELM
Shofu Dental Corporation
Dental · 85d