FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92185–92208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1997
SUNGLASSES
K973526 · HQY
Pyramid Handbags, Inc.
Ophthalmic · 28d
Cleared Oct 16, 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Oct 15, 1997
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
K962833 · LDF
Harmac Medical Products, Inc.
Cardiovascular · 474d
Cleared Oct 15, 1997
ZIRCONIA CERAMIC FEMORAL HEAD
K972690 · LZO
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 15, 1997
ABC TOTAL ELBOW PROTHESIS
K972691 · JDB
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 15, 1997
(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN...
K972807 · LPL
Benz Research and Development Corp.
Ophthalmic · 79d
Cleared Oct 15, 1997
ESTEEM 1.5T MRI SYSTEM
K972826 · LNH
Elscint Mr, Inc.
Radiology · 78d
Cleared Oct 15, 1997
ULTRAFAST CT SCANNER
K972879 · JAK
Imatron, Inc.
Radiology · 71d
Cleared Oct 15, 1997
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM
K972973 · IYO
Perception, Inc.
Radiology · 65d
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