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
91681–91704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1997
SERVO VENTILATOR 300A
K970839 · CBK
Siemens Elema AB
Anesthesiology · 221d
Cleared Oct 14, 1997
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K971501 · MNR
Bio-Logic Systems Corp.
Anesthesiology · 173d
Cleared Oct 14, 1997
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
K972686 · KPS
Smv America
Radiology · 89d
Cleared Oct 14, 1997
CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
K972762 · DQX
Cardio Metrics, Inc.
Cardiovascular · 82d
Cleared Oct 14, 1997
PORS ON LITE
K972910 · EJT
Degussa Corp.
Dental · 68d
Cleared Oct 14, 1997
TONGUE KLEAN
K973175 · LCN
Softek Ent.
Dental · 50d
Cleared Oct 14, 1997
LORI/LORI, LORI-S (LORI STOCK AID)
K973376 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Oct 14, 1997
ABC LINEARITY VERIFIERS
K973790 · JJY
Sc Calibrators & Controls, LLC
Chemistry · 8d
Cleared Oct 14, 1997
ABC CALIBRATION VERIFIERS
K973791 · JJY
Sc Calibrators & Controls, LLC
Chemistry · 8d
Cleared Oct 10, 1997
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · LHI
Baxter Healthcare Corp
General Hospital · 577d
Cleared Oct 10, 1997
OSTEOMED QUICKFIX
K962774 · DZL
Osteomed Corp.
Dental · 451d
Cleared Oct 10, 1997
PACER MODEL 100 INFUSION CONTROLLER
K963136 · LDR
Health Watch, Inc.
General Hospital · 423d
Cleared Oct 10, 1997
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX...
K964056 · JOH
Rusch Intl.
Anesthesiology · 366d
Cleared Oct 10, 1997
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
K965112 · DQO
Medline Industries, Inc.
Cardiovascular · 294d
Cleared Oct 10, 1997
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
K971628 · DQA
Somanetics Corp.
Anesthesiology · 161d
Cleared Oct 10, 1997
GALILEO HIGH RESOLUTION MICRO COUPLER
K971896 · HET
Netoptix Corp.
Obstetrics & Gynecology · 141d
Cleared Oct 10, 1997
ACCUMETER THEOPHYLLINE TEST
K972495 · KLS
Chemtrak, Inc.
Toxicology · 99d
Cleared Oct 10, 1997
PLATALLOY
K972607 · EJH
Aalba Dent, Inc.
Dental · 91d
Cleared Oct 10, 1997
STORZ MILLENNIUM VISCOUS FLUID SYSTEM
K972664 · MRH
Storz Instrument Co.
Ophthalmic · 86d
Cleared Oct 10, 1997
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM
K972684 · DYB
Innerdyne, Inc.
Cardiovascular · 85d
Cleared Oct 10, 1997
CBALK-1000 BLADE
K972727 · HNO
Howard Instruments, Inc.
Ophthalmic · 81d
Cleared Oct 10, 1997
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · GJS
Sigma Diagnostics, Inc.
Hematology · 74d
Cleared Oct 10, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972799 · LTT
Dade Microscan, Inc.
Microbiology · 74d
Cleared Oct 10, 1997
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
K972823 · MFD
A & A Medical, Inc.
Obstetrics & Gynecology · 72d