FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
130345–130368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892472 · LYY
Malatex Industries Sdn. Bhd.
General Hospital · 124d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVE (VINYL)
K892565 · LYZ
Kao Ying Industrial Co., Ltd.
General Hospital · 118d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892607 · LYZ
Disposable Products Co.
General Hospital · 121d
Cleared Aug 09, 1989
UNICATH A
K892849 · IZI
Xre Corp.
Radiology · 113d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES
K893267 · LYY
Hubei Provincial Medicines & Health...
General Hospital · 114d
Cleared Aug 09, 1989
LATEX EXAM GLOVES (MFG. GLOVELINE INDUSTRIES)
K893277 · LYY
China Representatives , Ltd.
General Hospital · 114d
Cleared Aug 09, 1989
PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER
K893644 · JAA
Perkins Mfg. Co.
Radiology · 86d
Cleared Aug 09, 1989
MRT-50A MOBILE
K893750 · LNH
Toshiba Medical Systems
Radiology · 83d
Cleared Aug 09, 1989
ARC-2F ACETABULAR CUP
K893785 · LWJ
Protek, Inc.
Orthopedic · 79d
Cleared Aug 09, 1989
CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER
K893832 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 77d
Cleared Aug 09, 1989
FLEXGARD SYRINGE PROTECTOR
K893862 · FMF
Dr. Gil Del Castillo
General Hospital · 76d
Cleared Aug 09, 1989
VISULIN TRANSPARENT ADHESIVE DRESSING
K894147 · KGX
James River Corp.
General & Plastic Surgery · 56d
Cleared Aug 09, 1989
B-D PATIENT EXAMINATION GLOVES
K894280 · LYY
Bd Becton Dickinson Vacutainer...
General Hospital · 47d
Cleared Aug 09, 1989
LATEX EXAMINATION GLOVES
K894306 · LYY
Ttj Industrial Co. , Ltd.
General Hospital · 49d
Cleared Aug 09, 1989
ORTHODERM CONVERTIBLE
K894353 · IOQ
Health Products, Inc.
Physical Medicine · 26d
Cleared Aug 09, 1989
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY
K894430 · DYB
Daig Corp.
Cardiovascular · 23d
Cleared Aug 09, 1989
KRR GLOVE, PATIENT EXAMINATION GLOVES
K894452 · LYY
Kerala Rubber & Reclaims, Ltd.
General Hospital · 51d
Cleared Aug 09, 1989
B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)
K894602 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 20d
Cleared Aug 08, 1989
EXTENDED COVERS, STERILE
K892069 · FFF
Amedic USA
Gastroenterology & Urology · 130d
Cleared Aug 08, 1989
GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE
K892071 · KNW
Amedic USA
Gastroenterology & Urology · 130d
Cleared Aug 08, 1989
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
K892354 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 151d
Cleared Aug 08, 1989
ASTRO BEHIND-THE-EAR HEARING AID
K892898 · ESD
Rexton, Inc.
Ear, Nose, Throat · 110d
Cleared Aug 08, 1989
GLASS MERCURY FILLED THERMOMETERS
K893602 · FLK
Smith & Nephew United, Inc.
General Hospital · 85d
Cleared Aug 08, 1989
FD 400 DENTAL STOOL
K893946 · KLC
Oriola OY Finndent
Dental · 69d