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
128977–129000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1989
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
K892530 · DYG
Arrow Intl., Inc.
Cardiovascular · 168d
Cleared Sep 26, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892760 · LYY
Saha Import & Export Co.
General Hospital · 168d
Cleared Sep 26, 1989
ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER
K892851 · FRO
Johnson & Johnson Patient Care, Inc.
General & Plastic Surgery · 161d
Cleared Sep 26, 1989
'JOBSTAR' PATIENT EXAMINATION GLOVES
K892972 · LYY
Kai Sik Towa Rubber Products Sdn
General Hospital · 167d
Cleared Sep 26, 1989
SWED MED STERILE VINYL EXAMINATION GLOVES
K893017 · LYZ
New England Glove Company
General Hospital · 167d
Cleared Sep 26, 1989
SAFETY TOUCH VINYL EXAMINATION GLOVES
K893105 · LYY
Fedin Brothers Co., Inc.
General Hospital · 165d
Cleared Sep 26, 1989
LATEX EXAMINATION GLOVES
K893336 · LYY
Lai Sun Industrial Co.
General Hospital · 159d
Cleared Sep 26, 1989
SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
K893435 · DYG
Cathlab Corp.
Cardiovascular · 147d
Cleared Sep 26, 1989
MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
K893471 · DXH
Medtronic Vascular
Cardiovascular · 145d
Cleared Sep 26, 1989
FLEXMEDICS GUIDEWIRE
K893626 · DQX
Flexmedics
Cardiovascular · 138d
Cleared Sep 26, 1989
CERAMIC FEMORAL HEAD
K893685 · LZO
Dow Corning Wright
Orthopedic · 133d
Cleared Sep 26, 1989
CN GLOVES
K893749 · LYY
C.N. Technocrats
General Hospital · 131d
Cleared Sep 26, 1989
OPUS MODEL 4001
K894065 · DXY
Ela Medical, Inc.
Cardiovascular · 110d
Cleared Sep 26, 1989
DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000
K894131 · DQY
Thermedics, Inc.
Cardiovascular · 105d
Cleared Sep 26, 1989
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
K894138 · CAF
Medipart Jerry Alexander
Anesthesiology · 105d
Cleared Sep 26, 1989
IMX TOTAL B-HCG
K894182 · JHI
Abbott Laboratories
Chemistry · 102d
Cleared Sep 26, 1989
ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
K894255 · KFM
St. Jude Medical, Inc.
Cardiovascular · 98d
Cleared Sep 26, 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · DXH
Hewlett-Packard Co.
Cardiovascular · 95d
Cleared Sep 26, 1989
FIRST IMPRESSION WITH CHLORHEXIDINE
K894281 · ELW
Coe Laboratories, Inc.
Dental · 95d
Cleared Sep 26, 1989
DMI PC HOLTER SCANNER
K894285 · DSI
Diagnostic Medical Instruments
Cardiovascular · 95d
Cleared Sep 26, 1989
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · DYB
Daig Corp.
Cardiovascular · 74d
Cleared Sep 26, 1989
LEONARDO INFORMATION SYSTEM
K894426 · CBK
Hamilton Medical, Inc.
Anesthesiology · 71d
Cleared Sep 26, 1989
PATIENT EXAMINATION GLOVES, LATEX
K894454 · LYY
Windwell Agencies Sdn. Bhd.
General Hospital · 96d
Cleared Sep 26, 1989
DANTEX VINYL EXAMINATION GLOVES
K894488 · LYZ
Dan Co., Ltd.
General Hospital · 70d