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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
113569–113592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1993
DENTA SAFE LATEX EXAMINATION GLOVES
K915514 · LYY
Dental Care Intl., Inc.
General Hospital · 515d
Cleared May 07, 1993
MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION
K921669 · LOS
Marquette Electronics, Inc.
Cardiovascular · 394d
Cleared May 07, 1993
SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI
K921930 · DPS
Siemens Medical Electronics
Cardiovascular · 378d
Cleared May 07, 1993
LAZER-TRACH TRACHEAL TUBE
K922894 · BTR
Sheridan Catheter Corp.
Anesthesiology · 325d
Cleared May 07, 1993
MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE
K923229 · LYU
Medical Armor Corp.
General Hospital · 310d
Cleared May 07, 1993
STOMA MEASURING DEVICE
K923692 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 288d
Cleared May 07, 1993
CRIT-LINE
K924167 · JPI
Noninvasive Medical Technology Corp.
Hematology · 261d
Cleared May 07, 1993
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
K924206 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 260d
Cleared May 07, 1993
MODEL 320 MR-COMPATIBLE PULSE OXIMETER
K924282 · DQA
Magnetic Resonance Equipment Corp.
Anesthesiology · 255d
Cleared May 07, 1993
MICROMANIPULATOR
K924457 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 247d
Cleared May 07, 1993
IRRIGATION/ASPIRATION TUBING SET
K925621 · GAA
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 182d
Cleared May 07, 1993
CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE
K925717 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 176d
Cleared May 07, 1993
COMFORTRON
K925821 · GZJ
M. D. Supply, Inc.
Neurology · 171d
Cleared May 07, 1993
BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA
K930620 · DWF
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared May 06, 1993
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550
K924205 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 259d
Cleared May 06, 1993
FLOWSCAN
K924413 · BZG
Electrocaine Medical System
Anesthesiology · 248d
Cleared May 06, 1993
CORDIS 9 F GUIDING CATHETER
K925131 · DQY
Cordis Corp.
Cardiovascular · 205d
Cleared May 06, 1993
MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE
K925342 · DQX
Medtronics Interventional Vascular
Cardiovascular · 198d
Cleared May 06, 1993
THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D
K925373 · LJT
Therex Corp.
General Hospital · 195d
Cleared May 06, 1993
EYEGLASS FRAME
K926157 · HQZ
Roi Factory Direct Frame Co.
Ophthalmic · 149d
Cleared May 06, 1993
ABBOTT VISION THEOPHYLLINE IIA
K926245 · KLS
Abbott Laboratories
Toxicology · 143d
Cleared May 06, 1993
BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU
K930593 · DWF
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared May 06, 1993
STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA
K930654 · LDJ
Solarcare Technologies Corp,Inc.
Toxicology · 86d
Cleared May 06, 1993
ECO TOOTHBRUSH
K930869 · EFW
Recycla-Dent, Inc.
Dental · 76d