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
128881–128904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1989
SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY
K894471 · GEX
Surgilase, Inc.
General & Plastic Surgery · 119d
Cleared Nov 14, 1989
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
K894711 · GTZ
Gen-Probe, Inc.
Microbiology · 111d
Cleared Nov 14, 1989
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION
K894712 · LQO
Gen-Probe, Inc.
Microbiology · 111d
Cleared Nov 14, 1989
HEMOSTASIS VALVE
K895214 · DYB
Applied Vascular Devices, Inc.
Cardiovascular · 88d
Cleared Nov 14, 1989
SELDINGER SINGLE WALL
K895454 · DRC
Advance Medical Designs, Inc.
Cardiovascular · 70d
Cleared Nov 14, 1989
SELDINGER PERCUTANEOUS 2 PC NEEDLES
K895455 · DRC
Advance Medical Designs, Inc.
Cardiovascular · 70d
Cleared Nov 14, 1989
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
K895583 · LSL
Gen-Probe, Inc.
Microbiology · 60d
Cleared Nov 14, 1989
TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
K895664 · CEM
Technicon Instruments Corp.
Chemistry · 55d
Cleared Nov 14, 1989
BREVET DISPOSABLE CONNECTORS
K895753 · DQY
Brevet, Inc.
Cardiovascular · 49d
Cleared Nov 14, 1989
QUANTIMETRIX BILIRUBIN CALIBRATORS
K895778 · JIS
Quantimetrix Medical Industries
Chemistry · 48d
Cleared Nov 14, 1989
TOTAL BILIRUBIN L.F.
K895822 · CIG
Sclavo, Inc.
Chemistry · 46d
Cleared Nov 14, 1989
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600
K896028 · CFR
American Research Products Co.
Chemistry · 29d
Cleared Nov 13, 1989
TDX(R) LITES(TM) LITHIUM
K894328 · JIH
Abbott Laboratories
Chemistry · 122d
Cleared Nov 13, 1989
.22 & 1.2 MICRON IV FILTERS
K894954 · FPB
Churchill Medical Systems, Inc.
General Hospital · 101d
Cleared Nov 13, 1989
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895123 · HGL
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Nov 13, 1989
BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
K895251 · KPN
C.R. Bard, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 13, 1989
CARDS O.S. (TM) HCG-URINE
K895390 · JHI
Pacific Biotech, Inc.
Chemistry · 75d
Cleared Nov 13, 1989
MOBILE X-RAY TELEVISION UNIT WHA-10A/B
K895394 · JAA
Shimadzu Corp.
Radiology · 68d
Cleared Nov 13, 1989
MODIFIED SPANTRON FRAME FREEZE
K895546 · JAA
Spantron, Inc.
Radiology · 61d
Cleared Nov 13, 1989
MODIFIED HOMECLINIC PREGNANCY TEST
K895560 · LCX
Vanguard Biomedical Corp.
Chemistry · 68d
Cleared Nov 13, 1989
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
K895585 · JIS
Hichem Diagnostics
Chemistry · 59d
Cleared Nov 13, 1989
API UNISCEPT KB
K895796 · JWY
Analytical Products, Inc.
Microbiology · 46d
Cleared Nov 13, 1989
ABBOTT IMX IGE
K895914 · DGC
Abbott Laboratories
Immunology · 34d
Cleared Nov 13, 1989
RADKOR DXG-650R
K895969 · IZO
Radkor, Inc.
Radiology · 32d